USFDA Recall - Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Complaints of Empty Capsules...

ISSUE: Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.

BACKGROUND: Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. Product was distributed through Northstar label to retail outlets nationwide.

RECOMMENDATION: Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase. Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

For more details on Recall CLICK HERE

USFDA Medical Device Safety and Recalls: Respironics California, Esprit V1000 and V200 Ventilators - Power Failure May Occur...

A recall has been issued for Respironics California, Esprit V1000 and V200 Ventilators because power failure may occur.  The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) or may fail and prevent the ventilator from switching back to AC power after using battery power. 

Additionally, if a battery is not present or is used up, the ventilators will not work. Failure of the power supply may cause the ventilator to shut off, which may result in too much carbon dioxide in a patient’s blood, not enough oxygen in the blood, or death. There have been no reports of death or serious injury related to this potential problem.  

For more information on recall, please CLICK HERE

Chaotic Labz Issues Voluntary Nationwide Recall of Mayhem Dietary Supplement Due to Undeclared Dexamethasone and Cyproheptadine

Chaotic Labz, Atkins, Arkansas, is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.

Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications. To date, Chaotic Labz has not received reports of these adverse effects related to this recall.

Mayhem is packaged in a clear bottle with yellow capsules associated with Lot #CLM061114 with an expiration date of 06/2016. The product can be identified by the brand known as Chaotic Labz and product name Mayhem, Appetite for Construction. This product was distributed nationwide to various Nutritional Supplement Retail Outlets and via the internet.

Chaotic Labz is notifying its distributors and customers by a formal recall notification and arranging for a return of all recalled products. Distribution of Mayhem will also be halted. Consumers, Distributors, and Retailers that have any of the recalled product should STOP USING and return immediately to the place of purchase. Contact your health care professional if you have experienced any adverse effects.

For more information CLICK HERE

Health Canada Recall Alert - Dangers of Swallowing Small Magnetic Parts from Mega Brands Magnetix Magnetic Building Sets

Issue

Health Canada is alerting the public to the danger to children of all ages posed by toys with small, powerful magnets or certain toys with small powerful magnetic parts. When more than one powerful magnet is swallowed in a short period of time, the magnets can attract one another while moving through the intestines. This can cause the intestines to twist, creating blockages or tearing of the intestinal walls. The results of swallowing small powerful magnets can be very serious and life-threatening. Swallowing incidents have often resulted in considerable damage to the gastrointestinal tissues and required emergency surgical treatment. For survivors, there can be serious lifelong health problems.
Health Canada recently received an incident report involving a three year old child who swallowed two magnetic parts (2.7 cm long rods) from a Mega Brands Magnetix Magnetic Building Set. The child received swift medical attention and sustained no injury.

Products affected:

Mega Brands Magnetix Magnetic Building Sets, sold in Canada from 2006 to 2009.
887,000 units from over 100 different Magnetix sets were sold in Canada. They contained up to 350 plastic building pieces in an assortment of colours (primary) and finishes (metallic, translucent and glow in the dark). The building pieces included 2.54 cm triangles, cylinder rods, flexors and curves, as well as 1.25 cm diameter steel balls.
Due to numerous serious injuries requiring emergency medical treatment, and one fatality in the United States in 2005, Magnetix Magnetic Building Sets sold before April 2006 were recalled in Canada in 2007. For these toys the small, powerful magnets were prone to separate from their plastic parts. Both younger and older children were involved in swallowing incidents. Mega Brands redesigned their Magnetix magnetic building parts so that the small, powerful magnets were more securely attached. Building sets with these modified parts were sold in Canada from April 2006 to March 2009. Even though the small magnets were no longer detaching during play, many of the magnetic building parts in these sets were small enough to be swallowed by a child, as was the case in the recent incident where two rods were swallowed.
At the time these products were originally sold, they met the relevant requirements for safety; however, those requirements have evolved. Today, certain toys with powerful magnets are considered a serious danger to children of all ages. These toys have powerful magnetic parts that are small enough to be swallowed or have small, powerful magnets that separate from parts.

What you should do

Consumers should immediately and safely discard all Mega Brands Magnetix Magnetic Building Sets. They are also reminded to discard any older-style Magnetix magnetic toys that were recalled in 2007. The toys should be disposed of in normal household garbage in such a way that they cannot be used or re-sold. Please note that the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

Health Canada Product Withdrawal : Gra-MaxX Gold: Seized from "ShopForYou", Vancouver, B.C. due to serious safety risks

Issue

An unauthorized health product, Gra-MaxX Gold, was seized by Health Canada as it contains an undeclared drug: N-Ethyl Tadalafil. The product is used to treat erectile dysfunction. The product was tested by Health Canada and removed from sale from ShopForYou, Robson Street, Vancouver, B.C. This product may pose serious risks to the health of Canadians, especially individuals with heart problems.

Products affected

Gra-MaxX Gold.

What you should do

• Consult with your doctor if you have used this product.
• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
• Report any adverse events to Health Canada.

  Who is affected

• Consumers who have used or purchased Gra-MaxX Gold.
  

  Background

  Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its analogs should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure.
  Individuals with heart problems including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they engage in sexual activity, especially if they use tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.
  Caffeine was also found in the product and was not listed on the product label. Caffeine may pose health risks to people sensitive to its effects.
   

Health Canada Harper Government Announces Passage of Vanessa's Law - Modernized Laws for Drugs and Medical Devices Mark a New Era in Canadian Patient Safety...

The Honourable Rona Ambrose, Minister of Health, joined by Member of Parliament for Oakville Terence Young, today celebrated a major milestone for patient safety in Canada - the passage of new legislation known as Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act). 

Delivering on a promise in the 2013 Speech from the Throne, the Act will protect Canadians from unsafe medicine by enabling the Government to:

• Recall unsafe products;
• Impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million per day instead of the current $5,000;
• Provide the courts with discretion to impose even stronger fines if violations were caused intentionally;
• Compel drug companies to revise labels to clearly reflect health risk information in plain language, including updates for health warnings for children;
• Compel drug companies to do further testing on a product, including when issues are identified with certain at-risk populations such as children;
• Enhance surveillance by requiring mandatory adverse drug reaction reporting by healthcare institutions;
• Require new transparency for Health Canada’s regulatory decisions about drug authorizations, both positive and negative;
• Require information about authorized Canadian clinical trials to be posted on a public registry;
• Better define confidential business information and disclose such information about a product if it may pose a serious risk to Canadians.

These new transparency measures build on the progress Health Canada has already achieved through its Regulatory Transparency and Openness Framework. The Framework commits Health Canada to a set of concrete initiatives that will make easy-to-understand regulatory health and safety information more available to Canadians. 

Quick Facts

• Vanessa's Law is named after Member of Parliament Terence Young’s daughter Vanessa, who died of a heart attack while on a prescription drug that later was deemed not safe and removed from the market.
• The Bill received all-party support in the House of Commons in light of its important new safety provisions that will benefit Canadians.
• The Protecting Canadians from Unsafe Drugs Act introduces the most profound and important changes to the Food and Drugs Act that have been made since it was introduced more than 50 years ago.

Quotes

“Today is an historic day for patient safety in Canada. As Minister of Health, nothing is more important to me than the safety of Canadians and their families. Through Vanessa’s Law, Canadians will be better informed about medications they are prescribed, and our Government will be empowered to recall unsafe products from the market. I am confident that Canadians will be better protected and lives will be saved as a result of these changes.” Rona Ambrose, Minister of Health

For more details CLICK HERE

MHRA Medicine Recall Alert : Zovirax Eye Ointment manufactured by The Welcome Foundation Limited trading as GlaxoSmithKline UK

Class 2 medicines recall

Action Within 48 Hours

Pharmacy and Wholesaler Level Recall

The Welcome Foundation Limited trading as GlaxoSmithKline UK

 

Zovirax Eye Ointment (Aciclovir 3%)

 

PL 0003/0150

 

 

Batch No.: 3L942 (Exp. Date Oct 2018, Pack Size: 4.5G, First Distributed 10JAN2014)

Batch No.: 3M941 (Exp. Date Jan 2019, Pack Size: 4.5G, First Distributed 07APR2014)

 

GlaxoSmithKline UK is recalling the below mentioned batches of Zovirax Eye Ointment as a precaution because the batches of pharmaceutical ingredient used in their manufacture were found to contain metal particles which were outside the upper specification limit for particle size. No complaints or adverse reaction reports relating to this issue have been received by the company to date.

Remaining stocks of the above batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock return please contact your original supplier.

There are no alternative batches of this product currently available and we understand that shortages are already being reported. Please find attached a copy of a Memo from UK Medical information (UKMI) advising on the availability of alternative therapies for the treatment of herpes simplex keratitis.

For more details CLICK HERE

USFDA Medical Device Recall Alert : Richard-Allan Scientific, 10% Neutral Buffered Formalin - May Contain Incorrect Concentration of Formalin

Recall Class: Class I

Date Recall Initiated: September 17, 2014

Products: 10% Neutral Buffered Formalin.

All other lots not included the table below, or similar products manufactured by Richard-Allan Scientific, are not affected by this recall.

Manufacturing Date: July 18, 2014, Distribution Dates: July 18 - September 17, 2014

Use: 10% neutral buffered Formalin is a liquid chemical used to preserve human tissue samples. These tissues are later examined for changes that could be caused by specific conditions or diseases, including cancer. The primary users of this solution are doctors’ offices, clinics, hospital emergency departments, and operating rooms.

Recalling Firm: 

Richard-Allan Scientific, subsidiary of Thermo Fisher Scientific

4481 Campus Drive

Kalamazoo, Michigan 49008

Reason for Recall: Richard-Allan Scientific discovered that the defective products returned from several customers were found to have from 0% to 3% Formalin content instead of the required 10%.  A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.

Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. The long-range health impact can include death or disability from a disease, such as cancer, that was not correctly diagnosed or treated, or an injury from using a treatment that may not have been needed.

USFDA Recall Alert - Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria

ISSUE:  Nutek Disposables, Inc. initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam's Club, Family Dollar, Fred's, and Diapers.com.

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of the bacteria Burkholderia cepacia (B. cepacia), in some of these products. B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia.

As of October 3, 2014, the date of the original withdrawal, the company had received only one report of irritation. Numerous reports of complaints have since been received by the company that include rash, irritation, infections, fever, gastro-intestinal issues, and respiratory issues, though these reports have not been confirmed to be related to the use of these products.

BACKGROUND: The company has not identified the cause of the problem, but is continuing to investigate. In the interim, Nutek has stopped shipping baby wipes manufactured at the facility.

RECOMMENDATION: Consumers who have purchased this product can return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-855-646-4351, Monday through Friday, 10 AM – 4 PM EDT. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

USFDA Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up

ISSUE: Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.

Consumers who intentionally avoid using Ibuprofen due to allergy, or other medical conditions, are advised that they may have inadvertently purchased Ibuprofen 200mg softgels, believing it was Naproxen Sodium 220mg tablets. Allergic reactions can range from mild irritation or hives to serious reactions such as anaphylaxes that may be life-threatening. The firm has not received any reports of adverse events related to this recall.

BACKGROUND: The recalled Assured brand drug products were distributed nationwide to Dollar Tree and sold via the Dollar Tree retail stores and internet site.

RECOMMENDATION: Contract Packaging Resources is notifying its distributors and customers directly and arranging for replacement of all recalled products. Consumers may return the recalled products to the place of purchase or contact the firm by phone at 336-252-3422, on Monday – Friday from 8:00 am to 4:00 pm (Eastern).

USFDA CDRH Medical Device Safety and Recalls: Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes...

A recall has been issued for the Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes because the electrodes will not work with Philips FR3 and FRx Automated External Defibrillators.  

Philips made changes to the design of their connectors for the FR3 and FRx AEDs, and because of these changes, the Covidien defibrillation electrodes will not work with these AEDs.  Use of these electrodes could cause a delay in delivering electrical therapy that is needed to revive patients. Additionally, their use could lead to severe health problems such as stroke, organ failure, or death if alternative defibrillator electrodes are not readily available. Covidien received two reports of injuries. There was a delay in resuscitating one patient which may have contributed to the subsequent death of the patient.  

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm419565.htm

MHRA Medical Device Alert : Babytherm infant warmers and open infant care units for newborns manufactured by Draeger Medical...

Babytherm infant warmers and open infant care units for newborns.

Manufactured by Draeger Medical.

Model numbers: 8004, 8010 and 8000WB.

This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.

Risk of baby falling out of the device.

Failure to follow the instructions for use for inserting the inner safety panels and locking the outer safety side panels may result in them opening unexpectedly.

Draeger sent a Field Safety Notice to its customers in August 2014 but hasn’t had enough replies to know if users have received and acted upon this information.

• Identify affected devices.

• Ensure users read the important information in the Field Safety Notice (FSN) and follow the instructions (see appendix) to ensure that the inner safety panels are in place and the outer side panels are securely locked into position.

• If the locking mechanism is not functioning, contact Draeger.

• Complete the acknowledgement sheet you received with the FSN and return it to Draeger.

Action by

All those who use these devices.

USFDA Medical Device Recall Alert : CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure...

Recall Class: Class I

Date Recall Initiated: August 5, 2014

Products: CareFusion 203, EnVe and ReVel ventilators

• Manufacturing Dates: May, 2009 - August 2014
• Distribution Dates: December 10, 2010 - August 6, 2014.

Lot Numbers: See Affected Lot Numbers below. (Added October 17, 2014)

Use: The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).  They are used in hospitals, during transport of a patient and at home to provide constant or intermittent respiratory support.

Recalling Firm:
CareFusion 203, Incorporated
17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341

Reason for Recall:
CareFusion 203 recalled these devices because of the potential for damage to their power cord adaptors which can cause loss of power and complete shut off.

The EnVe and ReVel ventilators can be operated using either batteries or external power sources (AC or auto lighters). The firm recalled these devices because they found that the pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death.

The company has received 256 reports of the incident with no reported injuries or deaths.

Public Contact: For questions regarding the operation and/or servicing of affected CareFusion ventilators in the United States, call the CareFusion Recall Center at 888.562.6018, Monday through Friday, 7:00 a.m. – 4:00 p.m., Pacific Time or via email at SupportCenter@carefusion.com.

USFDA : AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex, 60 Capsule Bottles Due to Possible Salmonella Contamination

AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of Salmonella, an organism which can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. To date, no illness or complaints have been reported to AMS Health Sciences, LLC.

A single lot of Saba Shark Cartilage Complex is the subject of this public announcement and recall as a result of a sample from one bottle that tested positive for Salmonella. This product is packaged in black screw-top bottles with the brand name “saba” in red letters, the product name “shark cartilage complex” in white letters, and a net quantity statement of “500 mg 60 capsules” in small white letters. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16, both of which are printed in black letters inside a white rectangle that is adjacent to the products “Suggested Use” instructions.

Product from this lot was sold to consumers through the internet site www.sabaforlife.com during the period of February through August 2014. AMS is initiating this recall out of caution for consumer health, even though numerous samples from the same Lot No. have tested negative for Salmonella.

Any consumer who purchased product with the lot number and expiration date above should dispose of it immediately and may request a refund by calling (866) 758-7222, Monday through Friday, 9:00 am – 5:00 pm (Central). If you have consumed the product and are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Health Canada seizes dangerous health products from online retailer...

Health Canada is warning Canadians of the serious risks to health associated with use of the unauthorized drug product Miracle Mineral Solution (MMS), which was sold as a treatment for serious diseases such as cancer through the website www.buymms.biz. MMS contains sodium chlorite, which is a chemical used mainly as a textile bleaching agent and disinfectant and may pose serious risks to health if ingested. 

An alternate format of MMS, labelled as CDS, is also available for sale on the website and would pose a similar risk.

Products affected

1. MMS (28% sodium chlorite and 50% citric acid)

2. CDS (chlorine dioxide 8000 ppm)

What you should do

• Stop using MMS products immediately.
• Consult their doctor or pharmacist if they have used or are using MMS products distributed by www.buymms.biz.
• Report any adverse events to Health Canada.

Who is affected

Canadians who have purchased Miracle Mineral Solution (MMS) products on the Internet from www.buymms.biz or any of its previously used company names: www.themmsstore.com, www.miraclemineralsupplement.com, and www.mms1.com.

Background

No drug products containing sodium chlorite have been approved by Health Canada for consumption by humans. Sodium chlorite is authorized in Canada for use as a germicide by veterinarians and as a hard surface disinfectant. Sodium chlorite is commonly used for bleaching textiles, pulp and paper, as well as in the generation of disinfectant for water treatment.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Health Canada : Voluntary Recall Alert Update : Nitroglycerine Spray Recall by Mylan Pharmaceuticals...

Health Canada is advising Canadians that Mylan Pharmaceuticals ULC has begun a voluntary recall of certain lots of its Mylan-Nitro Sublingual Spray 0.4 mg Per Metered Dose to the retail level. The recall is a result of the product potentially missing the "dip tube," which is part of the pump component. A missing "dip tube" could pose a problem with the delivery of nitroglycerin to the patient.

Health Canada had previously informed Canadians about this issue, but the recall was initially delayed due to the possibility of creating a shortage of this medically necessary heart drug on the Canadian market.

Health Canada would also like to inform Canadians that Mylan Pharmaceuticals ULC is now releasing product from a different lot that had been set aside and now verified to have a "dip tube" by the company. Consumers should verify that there is a checkmark sticker on the product's canister closure and carton, which demonstrates that it has the "dip tube".

In order to help ensure ongoing supply of the product, the company is advising consumers to continue using their current canister and only refill their prescription once one-third of their spray (70-75 doses) has been used.

Consumers should consult their pharmacist or healthcare practitioner if they have any concerns regarding the use of this product and report any adverse events to Health Canada.

USFDA Voluntary Recall Alert : LifeCare Flexible Intravenous Solutions by Hospira, Inc.because of Potential for Leakage...

ISSUE: Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. To date there have been no reports of adverse events associated with this issue for the impacted lots.

BACKGROUND: The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The root cause is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. The manufacturing issue that caused this incident has been addressed.

RECOMMENDATION: See the Firm Press Release for a list of the recalled lots. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.

USFDA Final Guidance and Webinar on “Distinguishing Medical Device Recalls from Medical Device Enhancements”

USFDA had issued a issued a final guidance document titled “Distinguishing Medical Device Recalls from Medical Device Enhancements.” The guidance clarifies for manufacturers how to determine when changes to a device constitute a recall and when they are considered a product enhancement. 

What's inside Guidance?

The guidance contains clear definitions and practical examples to help manufacturers distinguish a recall from an enhancement. Correctly identifying a change to a device as a recall reduces the time between identification of a device defect/failure and public notification. Clarifying when a change to a device represents a recall or an enhancement will help manufacturers better understand when reporting device changes to the FDA is required.

Webinar on the above Guidance Details:

Date: November 5, 2014

Time: 1:30 PM – 3:00 PM, Eastern Time
To ensure you are connected, log-in by 1:15 PM.

To hear the presentation and ask questions: Dial: 1-888-469-0882; passcode: CDRH

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW9036971, Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm

USFDA Recall Alert - Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit

AUDIENCE: Pharmacy, Nursing, Health Professional

ISSUE: Hospira, Inc. issued a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01 NOV 2015. The product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.

This recall is being carried out to the medical facility/retail level (both human and veterinary).

BACKGROUND: There have been no adverse events or complaints reported for the affected lot.

RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Please notify all users in your facility. If you have further distributed the recalled product please notify any accounts or additional locations which may have received the recalled product from you and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the medical facility/retail level. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle.

For additional assistance, call Stericycle at 1-844-861-6215 between the hours of 8am to 5pm ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

USFDA CDRH Medical Device Recall Alert : Teleflex Medical, Hudson RCI Pediatric Anesthesia Breathing Circuits - Circuit Ends May Crack or Break

Hudson RCI Pediatric Anesthesia Breathing Circuits

Recall Class: Class 

Date Recall Initiated: September 8, 2014

Devices: Hudson RCI Pediatric Anesthesia Breathing Circuits.  

See complete listing of recalled devices

• Manufacturing Dates: March 2013 to July 2014
• Distribution Dates: June 2013 to May 2014

Use: Anesthesia circuits deliver a mixture of anesthesia and/or other gases from a mechanical ventilator to a patient. This device is used in hospitals to care for pediatric patients.

Recalling Firm:
Teleflex Medical, 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Reason for Recall:

The ends of the devices may crack or break before or during use. This could cause serious health risks, including delayed patient treatment and breathing difficulties if not replaced immediately.

Use of this device may also cause death.

Public Contact: For questions about this recall, contact the firm’s Customer Service at cs@teleflex.com or 1-866-246-6990, Monday - Friday, 8:00 a.m. - 7:00 p.m., Eastern Time, or call your local sales representative.