Status
Terminated
Drug Enforcement D-806-2013
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Classification
Class I
Report Date
July 24, 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
- 37,303 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-806-2013
- Event ID
- 64657
- Recall initiation date
- March 18, 2013
- Center classification date
- July 17, 2013
- Code info
- 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
- More code info
- —