Medications & Supplements/Prescription Drugs

Apotex Inc.: Piperacillin and Tazobactam Injection Recalled for Subpotency and Impurities

Agency Publication Date: June 5, 2018

Summary

Apotex Inc. is recalling 135,146 vials of Piperacillin and Tazobactam for Injection, USP (3.375 gram/vial and 4.5 gram/vial). These prescription antibiotics are being recalled because they are subpotent, meaning they contain high levels of impurities that cause the medication to be less effective than required. The recall affects 10-count single-use vial cartons distributed nationwide across the United States. Using a medication with decreased potency may fail to treat the underlying infection effectively.

Risk

The high levels of impurities in these vials result in decreased potency of the antibiotic. Using subpotent medication can lead to treatment failure for bacterial infections, which may cause a patient's condition to worsen or result in serious life-threatening complications.

What You Should Do

Check your supply for Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial (NDC 60505-0687-4). Affected lot numbers include: 501G014 (Exp. 05/2018); 501G015 (Exp. 09/2018); 501G016 through 501G023 (Exp. 10/2018); 501G024 through 501G030 (Exp. 11/2018); 501H001 through 501H008 (Exp. 12/2018); 501H009 (Exp. 04/2019); 501H012, 501H013 (Exp. 06/2019); and 501H018, 501H019 (Exp. 09/2019).
Check your supply for Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial (NDC 60505-0688-4). Affected lot numbers include: 502H001 (Exp. 01/2019); 502H003, 502H004, 502H005 (Exp. 04/2019); and 502H009, 502H012 (Exp. 05/2019).
Immediately contact your healthcare provider or pharmacist if you possess any of the affected lots for guidance on alternative treatments and to report any health concerns.
Return any unused product from the affected lots to the pharmacy where it was purchased for a refund, and contact Apotex Inc. for further instructions regarding the return process.
For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Piperacillin and Tazobactam for Injection, USP (3.375 gram/vial)

Model:

NDC 60505-0687-4

D-0839-2018

Lot Numbers:

501G014 (Exp. 05/2018)

501G015 (Exp. 09/2018)

501G016 (Exp. 10/2018)

501G017 (Exp. 10/2018)

501G018 (Exp. 10/2018)

501G019 (Exp. 10/2018)

501G020 (Exp. 10/2018)

501G021 (Exp. 10/2018)

501G022 (Exp. 10/2018)

501G023 (Exp. 10/2018)

501G024 (Exp. 11/2018)

501G025 (Exp. 11/2018)

501G026 (Exp. 11/2018)

501G027 (Exp. 11/2018)

501G028 (Exp. 11/2018)

501G029 (Exp. 11/2018)

501G030 (Exp. 11/2018)

501H001 (Exp. 12/2018)

501H002 (Exp. 12/2018)

501H003 (Exp. 12/2018)

501H004 (Exp. 12/2018)

501H005 (Exp. 12/2018)

501H006 (Exp. 12/2018)

501H007 (Exp. 12/2018)

501H008 (Exp. 12/2018)

501H009 (Exp. 04/2019)

501H012 (Exp. 06/2019)

501H013 (Exp. 06/2019)

501H018 (Exp. 09/2019)

501H019 (Exp. 09/2019)

Date Ranges: Exp. 05/2018 - 09/2019

Product: Piperacillin and Tazobactam for Injection, USP (4.5 gram/vial)

Model:

NDC 60505-0688-4

D-0840-2018

Lot Numbers:

502H001 (Exp. 01/2019)

502H003 (Exp. 04/2019)

502H004 (Exp. 04/2019)

502H005 (Exp. 04/2019)

502H009 (Exp. 05/2019)

502H012 (Exp. 05/2019)

Date Ranges: Exp. 01/2019 - 05/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80063

Status: Resolved

Manufacturer: Apotex Inc.

Sold By: Hospitals; Pharmacies

Manufactured In: Canada, India

Units Affected: 2 products (121693 vials; 13453 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your supply for Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial (NDC 60505-0687-4). Affected lot numbers include: 501G014 (Exp. 05/2018); 501G015 (Exp. 09/2018); 501G016 through 501G023 (Exp. 10/2018); 501G024 through 501G030 (Exp. 11/2018); 501H001 through 501H008 (Exp. 12/2018); 501H009 (Exp. 04/2019); 501H012, 501H013 (Exp. 06/2019); and 501H018, 501H019 (Exp. 09/2019).

Check your supply for Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial (NDC 60505-0688-4). Affected lot numbers include: 502H001 (Exp. 01/2019); 502H003, 502H004, 502H005 (Exp. 04/2019); and 502H009, 502H012 (Exp. 05/2019).

Immediately contact your healthcare provider or pharmacist if you possess any of the affected lots for guidance on alternative treatments and to report any health concerns.

Return any unused product from the affected lots to the pharmacy where it was purchased for a refund, and contact Apotex Inc. for further instructions regarding the return process.

For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Piperacillin and Tazobactam for Injection, USP (3.375 gram/vial)

Model:

NDC 60505-0687-4

D-0839-2018

Lot Numbers:

501G014 (Exp. 05/2018)

501G015 (Exp. 09/2018)

501G016 (Exp. 10/2018)

501G017 (Exp. 10/2018)

501G018 (Exp. 10/2018)

501G019 (Exp. 10/2018)

501G020 (Exp. 10/2018)

501G021 (Exp. 10/2018)

501G022 (Exp. 10/2018)

501G023 (Exp. 10/2018)

501G024 (Exp. 11/2018)

501G025 (Exp. 11/2018)

501G026 (Exp. 11/2018)

501G027 (Exp. 11/2018)

501G028 (Exp. 11/2018)

501G029 (Exp. 11/2018)

501G030 (Exp. 11/2018)

501H001 (Exp. 12/2018)

501H002 (Exp. 12/2018)

501H003 (Exp. 12/2018)

501H004 (Exp. 12/2018)

501H005 (Exp. 12/2018)

501H006 (Exp. 12/2018)

501H007 (Exp. 12/2018)

501H008 (Exp. 12/2018)

501H009 (Exp. 04/2019)

501H012 (Exp. 06/2019)

501H013 (Exp. 06/2019)

501H018 (Exp. 09/2019)

501H019 (Exp. 09/2019)

Date Ranges: Exp. 05/2018 - 09/2019

Product: Piperacillin and Tazobactam for Injection, USP (4.5 gram/vial)

Model:

NDC 60505-0688-4

D-0840-2018

Lot Numbers:

502H001 (Exp. 01/2019)

502H003 (Exp. 04/2019)

502H004 (Exp. 04/2019)

502H005 (Exp. 04/2019)

502H009 (Exp. 05/2019)

502H012 (Exp. 05/2019)

Date Ranges: Exp. 01/2019 - 05/2019