Medications & Supplements/Prescription Drugs

Pfizer Inc.: Unasyn Injection Recalled for Presence of Particulate Matter

Agency Publication Date: June 9, 2020

Summary

Pfizer Inc. is recalling 94,320 units of Unasyn (ampicillin sodium/sulbactam) for injection, 1.5 g per vial, because particulate matter was found in the medication after it was prepared for use. Unasyn is a prescription antibiotic used to treat various bacterial infections. If you have this medication, you should contact your healthcare provider or pharmacist immediately for guidance before administration. Pfizer initiated this recall by letter after discovering the particles, which should not be present in an injectable drug.

Risk

The presence of solid particles in an injectable medication can cause serious health issues, including local irritation, inflammation, or the blockage of blood vessels, which could lead to organ damage or other life-threatening complications.

What You Should Do

Check your medication vials and cartons for Unasyn (ampicillin sodium/sulbactam) for injection, 1.5 g per vial, with lot number 3301612 and an expiration date of 02/2022.
Identify the affected product by looking for vial NDC 0049-0013-81 or carton NDC 0049-0013-83 on the packaging.
If you have this specific lot, do not use the medication and contact your healthcare provider or pharmacist immediately for further instructions.
Return any unused vials or cartons from this lot to your pharmacy to receive a refund.
Contact Pfizer Inc. at their New York headquarters or through your healthcare provider for additional information regarding this recall.
For further questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return

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

Affected Products

Product: Unasyn (ampicillin sodium/sulbacatam) for injection (1.5 g per vial)

Model:

vial NDC 0049-0013-81

carton NDC 0049-0013-83

Recall #: D-1306-2020

Lot Numbers:

3301612 (EXP 02/2022)

Date Ranges: 02/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85754

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: pharmacies; hospitals

Manufactured In: Italy, United States

Units Affected: 94320 units

Distributed To: Nationwide

Agency Last Updated: June 12, 2020

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 medication vials and cartons for Unasyn (ampicillin sodium/sulbactam) for injection, 1.5 g per vial, with lot number 3301612 and an expiration date of 02/2022.

Identify the affected product by looking for vial NDC 0049-0013-81 or carton NDC 0049-0013-83 on the packaging.

If you have this specific lot, do not use the medication and contact your healthcare provider or pharmacist immediately for further instructions.

Return any unused vials or cartons from this lot to your pharmacy to receive a refund.

Contact Pfizer Inc. at their New York headquarters or through your healthcare provider for additional information regarding this recall.

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