Sagent Recalls Ketorolac Tromethamine Injections (NSAID) Due to Lack of Sterility Assurance

Sagent Recalls Ketorolac Tromethamine Injections (NSAID) Due to Lack of Sterility Assurance

Sagent Pharmaceuticals, Inc. announced a nationwide recall of one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) – an NSAID – due to a lack of sterility assurance.

Ketorolac Tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term (up to five days) management of moderately severe acute pain that requires analgesia at the opioid level. Routine simulation of the manufacturing process found microbial growth, representing the potential introduction of microorganisms into the products.

Patients administered contaminated products intravenously are at risk of sepsis, a serious bloodstream infection, potentially leading to shock and death.

The recalled lot number is M813513 with an expiration date of February 2020. The product was supplied in 2 ml glass tubular vials and was distributed between January through March of 2019.

For more information, see the FDA Safety Alert.