PlainRecalls
FDA Drug Critical Class I Terminated

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0

Reported: August 14, 2013 Initiated: May 10, 2013 #D-835-2013

Product Description

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0

Reason for Recall

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Details

Recalling Firm
Apotex Corp.
Units Affected
52,398 vials
Distribution
Nationwide
Location
Weston, FL

Frequently Asked Questions

What product was recalled?
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. Recalled by Apotex Corp.. Units affected: 52,398 vials.
Why was this product recalled?
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Critical. Recall number: D-835-2013.