Apotex Corp., on behalf of the manufacturer and pharmaceutical company Hospira, Inc (HSP) said it is conducting a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams as it fears the impacted lots may show precipitation or crystallization in IV bag or IV line after reconstitution. Hospira is investigating to get to the bottom of the issue. The company, however, has not so far received any complaints of adverse events related to the recall.
Hospira had earlier stated that administration of precipitated Piperacillin or Tazobactam in an IV bag or IV line may result in local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis. Further, precipitation of the drug may not allow delivering a needed therapeutic dose of piperacillin and tazobactam, thus resulting in inadequate treatment of the targeted infection which in turn could lead to a host of adverse health consequences.
The recalled product is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptable, ß-lactamase producing strains of the designated microorganisms in the specified conditions such as, appendicitis, uncomplicated and complicated skin and skin structures infections, postpartum endometritis or pelvic inflammatory disease, community acquired pneumonia and nosocomial pneumonia.
The product is packaged in 300 mL glass vials for reconstitution and can be identified by NDC number 60505-0773-00 and UPC 360505077304.
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