Drug Enforcement D-835-2013

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

Status

Terminated

Classification

Class I

Report Date

August 14, 2013

Termination Date

January 8, 2018

Product Information

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
Product quantity
52,398 vials
Reason for recall
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Apotex Corp.
Address
2400 N Commerce Pkwy Ste 400, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-835-2013
Event ID
65196
Recall initiation date
May 10, 2013
Center classification date
August 2, 2013
Code info
Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14
More code info
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