Apotex Recalls Product Due to Elevated Levels of Impurities

The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
May 16, 2018
By BioPharm International Editors

Apotex Corp. announced on May 14, 2018 that it 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 level. The product is manufactured by Hospira, Inc., a Pfizer Company, and distributed by Apotex. The recall comes after elevated levels of impurities were found, which may result in decreased potency, according to the company.

The recalled products are packaged in cartons containing 10 single-use vials and were distributed nationwide to wholesalers and one distributor, who have been notified of the recall by the company. More information on the affected lots can be found online.

Piperacillin and Tazobactam for injection is a combination penicillin-class antibacterial and β- lactamase inhibitor used for the treatment of intra-abdominal infections, skin and skin structure infections, female pelvic infections, community-acquired pneumonia, and hospital acquired pneumonia. According to the company, decreased potency of these products could result in worsening of the infection and/or toxicities, such as liver, renal, and hematological toxicities.

As of May 14, no adverse events have been reported. Adverse events may be reported to FDA through its MedWatch program.

Source: FDA

 

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