
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.
Apotex Corp.
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
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.
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