Drug product
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
D-835-2013
Product summary
- Firm
- Apotex Corp.
- Event
- Event 65196
- Status
- Terminated
- Classification
- Class I
- Quantity
- 52,398 vials
- Official record key
drug-enforcement:D-835-2013
Official wording
Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.