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Apotex Corp. Issues Voluntary Recall

On April 26, 2013 Apotex Corp. announced that it would be conducting a voluntary recall of 15 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 due to the possibility of precipitation/crystallization in IV Bag or IV Line Upon Reconstitution. The recall was requested by Hospira, manufacturer of the product. Apotex has notified it’s customers and arranged for the return of the recalled product. The FDA is aware of the recall.

Adverse Effects

Administration of precipitated Piperacillin/Tazobactam in an IV bag or IV line could result in phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis. The product was distributed nationwide in the U.S. No adverse events related to the recall have been reported.

The product is used to treat patients with infections, postpartum endometritis or pelvic inflammatory disease, community acquired pneumonia and nosocomial pneumonia. The precipitation of the drug will result in inadequate treatment for infection.

Existing Inventory

Use and distrubution of the product should immediatly be stopped. Anyone with an existing inventory should quarantine the recalled lots and call GENCO at 1-877-674-2078 (Monday-Friday, 7 AM to 5 PM).

Reporting A Problem

To report adverse events or product complaints call Hospira Global Complaint Management at 1-800-441-4100 (Monday-Friday, 8AM-5PM)

To report medical inquiries call Hospira Medical Communications at 1-800-615-0187 (avilable 24/7)

Any adverse reactions or quality issues should be reported to the FDA and MedWatch Adverse Events Program either online: http://www.fda.gov/MedWatch/report.htm, through regular mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm, or through fax: 1-800-FDA-0178