FDA Drug recall D-806-2013
Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt
- FDA Drug
- Class I
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class I recall of Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt by Apotex, citing crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-806-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-03-18 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
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.
Reason
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Identifiers
| code_info | Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-806-2013%22
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