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-806-2013
Product summary
- Firm
- Apotex Corp.
- Event
- Event 64657
- Status
- Terminated
- Classification
- Class I
- Quantity
- 37,303 vials
- Official record key
drug-enforcement:D-806-2013
Official wording
Reason: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Code information: Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.