USFDA : Sagent Pharmaceuticals Initiated a Nationwide Voluntary Recall of 3 Lots of Ketorolac Tromethamine Injection, USP, 30mg/ml Due to Labeling the Product with the Incorrect Expiration Date

Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP, 30mg/mL to the user level due to labeling the product with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

 Sagent is not aware of any adverse patient events resulting from the use of this product.

The lot numbers being recalled are MP5021, MP5024 and MP5025 which were distributed to hospitals, wholesalers and distributors nationwide from September 17, 2014 through October 1, 2014. Ketorolac Tromethamine Injection, USP, 30mg/mL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting, and is supplied in a single-dose vial.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lots of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.