Medications & Supplements/Prescription Drugs

Pfizer Inc.: Meropenem for Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: October 24, 2018

Summary

Pfizer Inc. is recalling approximately 71,075 vials of Meropenem for Injection (1 gram per vial), an intravenous antibiotic used to treat serious bacterial infections. The recall was initiated because the vials may have lost their container integrity, which means the medicine inside might not be sterile. Using a non-sterile injectable drug can lead to life-threatening infections, particularly in hospitalized patients with weakened immune systems. These products were distributed nationwide in the U.S. and Puerto Rico between approximately 2017 and 2018.

Risk

A loss of container integrity allows bacteria or other contaminants to enter the vial, compromising the sterility of the medication. Injecting a contaminated drug directly into a patient's bloodstream can cause serious systemic infections or sepsis.

What You Should Do

Immediately check your medical supplies for Meropenem for Injection, 1 gram/vial, packaged in 25-vial cartons with NDC carton code 0409-3506-01 and NDC vial code 0409-3506-11.
Verify if your product belongs to Lot 609G047 with an expiration date of 10/2018.
If you have this specific lot, stop using the product immediately and quarantine it to ensure it is not administered to patients.
Contact your healthcare provider or pharmacist for guidance on alternative treatments and return any unused product to the place of purchase for a refund.
Healthcare facilities and distributors should contact Pfizer Inc. at 1-888-723-3332 to arrange for the return of the affected product.
For additional questions or to report adverse events, 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 refund

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

Affected Products

Product: Meropenem for Injection, USA (I.V.), 1 gram/vial (25 vials per carton)

Model:

NDC carton: 0409-3506-01

NDC vial: 0409-3506-11

Recall #: D-0095-2019

Lot Numbers:

609G047 (Exp 10/2018)

Date Ranges: October 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81311

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; hospitals; healthcare facilities

Manufactured In: United States

Units Affected: 71,075 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

Immediately check your medical supplies for Meropenem for Injection, 1 gram/vial, packaged in 25-vial cartons with NDC carton code 0409-3506-01 and NDC vial code 0409-3506-11.

Verify if your product belongs to Lot 609G047 with an expiration date of 10/2018.

If you have this specific lot, stop using the product immediately and quarantine it to ensure it is not administered to patients.

Contact your healthcare provider or pharmacist for guidance on alternative treatments and return any unused product to the place of purchase for a refund.

Healthcare facilities and distributors should contact Pfizer Inc. at 1-888-723-3332 to arrange for the return of the affected product.

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