D-0839-2018 Class I Terminated
FDA drug recall D-0839-2018 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: 121693 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
- 121693 vials
Product Description
Piperacillin and Tazobactam for Injection, USP 3.375 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 60505-0687-4
Reason for Recall
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Distribution Pattern
Nationwide in the USA.
Code Information
Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023 Exp. 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029 501G030, Exp. 11/2018, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0839-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026