Apotex announced a voluntary nationwide recall of 15 lots of Piperacillin and Tazobactam for Injection 40.5g on behalf of Hospira. This recall resulted because the affected lots may show precipitation/crystallization in IV bag or IV line after reconstitution.
The affected lots are packaged in 300mL glass vials for reconstitution and have NDC #60505-0773-00 with expiration dates ranging from 4/2013–4/2014. The full product list can be viewed here. Apotex will notify its direct account customers by sending the recall notification letters and is arranging for product return of all recalled products.
Administration of precipitated Piperacillin/Tazobactam in an IV bag or IV line may result in phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis. The precipitation may also prevent delivery of a therapeutic dose, thus resulting in inadequate treatment of the targeted infection.
Piperacillin/Tazobactam is a broad-spectrum penicillin + β-lactamase inhibitor combination indicated for the treatment of susceptible skin and skin structure infections, moderately severe community-acquired pneumonia, moderate to severe nosocomial pneumonia, postpartum endometritis, pelvic inflammatory disease, complicated appendicitis, and peritonitis.
For more information call (877) 674-2078 or visit www.apotex.com.