D-0840-2018 Class I Terminated
FDA drug recall D-0840-2018 was initiated by Apotex Inc. on May 8, 2018 and is designated Class I. Reason for recall: Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency The recall status is terminated (terminated Oct 3, 2023). Affected quantity: 13453 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 23, 2018
- Initiation Date
- May 8, 2018
- Termination Date
- Oct 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13453 vials
Product Description
Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
Reason for Recall
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0840-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026