Drug Safety Alerts

Piperacillin and Tazobactam for Injection Consumer-Level Recall

5/14/18

On May 14, 2018, Apotex issued a consumer-level recall of piperacillin and tazobactam for injection. This recall was issued due to product containing elevated levels of impurities that may result in decreased potency. This recall is to the Consumer level. The decreased potency of piperacillin and tazobactam could result in worsening of the infection under treatment and under extreme circumstances lead to serious morbidities depending upon the severity of the illness. Elevated levels of impurities may result in various toxicities, such as liver, renal, and hematological toxicities. There have not been any reports of adverse events related to this recall to date.

A complete list of the affected products is provided here:

CVS Caremark Response: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Apotex at 1- 800-706-5575, Monday through Friday, 8:30 am to 5:00 pm (ET). You may also contact the U.S. Food and Drug Administration (FDA) toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.