Why it was recalled
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0839-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 8, 2018
- FDA report date
- May 23, 2018
- Quantity
- 121693 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0839-2018, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Terminated
- Country
- Canada
- Event ID
- 80063
- Address
- 150 Signet Dr
- 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.
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0839-2018
- Classification
- Class I
- Recalling firm
- Apotex Inc.
- Product quantity
- 121693 vials
- Termination date
- Oct 3, 2023
- Reason for recall
- Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2018