Apotex, on behalf of Hospira, has initiated a US-wide voluntary recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, over concerns that the recalled lots may show precipitation or crystallization in IV bag or IV line after reconstitution.
Hospira had stated that administration of precipitated Piperacillin or Tazobactam in an IV bag or IV line may cause local reactions such as phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis.
Additionally, the precipitation may block the much needed therapeutic dose of piperacillin and tazobactam, resulting in inappropriate treatment of the targeted infection. This could result in adverse health issues or may lead to permanent impairment of a body function.
The recalled product is meant for treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptable, -lactamase producing strains of the designated microorganisms in the specified conditions such as appendicitis, nosocomial pneumonia, etc.
The product can be identified by NDC number 60505-0773-00 and UPC 360505077304.
The recalled lots have been manufactured by Hospira and distributed across the US by Apotex.
