Nationwide Recall of Mislabeled NSAID for Post-Operative Pain Relief

Three lots of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials manufactured by Cadila Healthcare Limited and distributed by Sagent Pharmaceuticals, Inc., are the subject of a nationwide recall. Sagent initiated the recall to the user level due to labeling the product with the incorrect expiration date. The labeled expiration date exceeds the known stability of the product.


Ketorolac Tromethamine Injection, USP, 30mg/mL is a non-steroidal 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.


The product bears the NDC numbers 25021-701-01 and 25021-701-02. 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.


See the Recall


See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians


See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication