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: July 24, 2013 Initiated: March 18, 2013 #D-806-2013

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
37,303 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: 37,303 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 July 24, 2013. Severity: Critical. Recall number: D-806-2013.