Drug Safety Alerts

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL - User-level Recall

05/01/2019

On May 1, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a User-level Recall of Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL NDC # 25021-0701-02 manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. This recall was issued due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

This recall affects lot number M813513 exp. Feb-2020.

The lot number being recalled was distributed to hospitals, wholesalers and distributors nationwide from January – March 2019.

Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis (serious condition resulting from the presence of harmful microorganisms in the blood and the body’s response to their presence, potentially leading to shock and death). The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

Ketorolac Tromethamine Injection, USP, is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.

CVS Caremark Response: This product is not carried by CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Sagent Pharmaceuticals toll-free at 1‑866‑625-1618 or visit www.sagentpharma.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.