D-835-2013 Class I Terminated
FDA drug recall D-835-2013 was initiated by Apotex Corp. on May 10, 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: 52,398 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 14, 2013
- Initiation Date
- May 10, 2013
- Termination Date
- Jan 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,398 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 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-835-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026