Alkem Laboratories's US Subsidiary Ascend Labs banned from Manufacturing and Distributing Drugs in US...

The US Subsidiary Ascend Laboratories of India-based Alkem Laboratories has been banned from manufacturing and distribution of medicines in the US for selling unapproved drugs.

The US Food and Drug Administration informed through a statement that a federal judge from the US District Court entered a consent decree for permanent injunction against Ascend Laboratories, LLC -- the US subsidiary of Alkem Laboratories -- on October 10. 

The US Department of Justice filed the consent decree on behalf of the USFDA, it added.

"The consent decree requires Ascend Laboratories to post bond for the release of their unapproved drug products seized by US Marshals in May 2014, which the company is then responsible for destroying under the FDA's supervision," the statement said. 

The consent decree also prohibits Ascend Laboratories and all other associated persons who act in concert with the company from manufacturing and distributing unapproved drugs until the company obtains FDA approval, it added.

The USFDA inspected Ascend Laboratories' New Jersey facility in November 2013 and Masters Pharmaceutical's Cincinnati warehouse in February 2014.

"The inspections revealed that Ascend Laboratories was marketing drug products without FDA approval and adequate directions for use," the statement said.

"Manufacturing and distributing unapproved prescription drugs puts patients' health at risk since they have not been found to be safe, effective or made using quality manufacturing practices," FDA's Center for Drug Evaluation and Research acting director Ilisa Bernstein said.

"Companies that fall short of our requirements risk FDA action to stop the distribution of their products," Bernstein added.

Alkem Laboratories is one of the top seven pharmaceutical companies in India. It has 15 manufacturing plants located across the country of which four are USFDA approved.

USFDA seeks permanent injunction against Pharmaceutical Innovations, Inc.

The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.

The Newark, New Jersey company’s products include ultrasound, mammography, and electrocardiogram gels, and scanning pads. These products are medical devices used for diagnostic purposes in health care settings.

The complaint alleges that the defendants did not manufacture their devices in conformity with the current good manufacturing practice requirements of the Federal Food, Drug, and Cosmetic Act, and that they distributed their products nationwide without required premarket approval or clearance.

The complaint also details that U.S. marshals, acting at the request of the FDA, seized certain lots of Other-Sonic Generic Ultrasound Transmission Gel from the company in April 2012. The seizure took place after FDA laboratories found in those lots significant amounts of Pseudomonas aeruginosa and Klebsiella oxytoca – bacteria that pose serious risks of infection, such as pneumonia, to people exposed to the product. The FDA is aware of people who were infected with Pseudomonas aeruginosa after having undergone a surgical procedure at a Michigan hospital involving Other Sonic Generic Ultrasound Transmission Gel. On April 18, 2012, FDA issued a safety alert to health care professionals and facilities to stop using the contaminated product.

“Despite multiple warnings by the FDA over the past three years, and promises to correct the numerous ongoing violations, the defendants continued to violate the law,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “This presents serious health risks to patients who used and continue to use the company’s products. By taking this action, the FDA is demonstrating its commitment to protecting the public from the dangers of adulterated and misbranded medical products.”

The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA on Oct. 2, 2014, in the U.S. District Court for the District of New Jersey.