Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency

Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.

Risk Statement: 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.