Sagent Pharmaceuticals, Inc. Recalls Ketorolac Tromethamine Injection, USP, 60mg/2mL

May 2, 2019
Pharmaceutical Technology Editors

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

Sagent Pharmaceuticals, Inc. announced on April 30 that it was voluntarily recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) because of sterility assurance problems. The recall was initiated after microbial growth was detected during a routine simulation of the manufacturing process. The recalled product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc to hospitals, wholesalers, and distributors nationwide from January–March 2019. 

While the company states that no batches of distributed products have been identified as containing microorganisms and it has not received reports of any adverse events, there is a risk of sepsis infection if the product is administered intravenously. “The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated,” the company stated in a press release.

Ketorolac Tromethamine Injection, USP, is a nonsteroidal anti-inflammatory drug (NSAID) used for the management of moderately severe acute pain that requires analgesia at the opioid level.

Source: FDA