D-806-2013 Class I Terminated
FDA drug recall D-806-2013 was initiated by Apotex Corp. on Mar 18, 2013 and is designated Class I. Reason for recall: Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. The recall status is terminated (terminated Jan 8, 2018). Affected quantity: 37,303 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 24, 2013
- Initiation Date
- Mar 18, 2013
- Termination Date
- Jan 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,303 vials
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.
Reason for Recall
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Distribution Pattern
Nationwide
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-806-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026