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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug

Mylan Institutional LLC: Presence of Particulate Matter

Agency Publication Date: August 14, 2015
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Affected Products

Product: Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.

Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15

Product: Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

Lot #: 7801221, 7801222, Exp 03/16

Lot Numbers:
7801221
Product: Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Lot #: 7801273, 7801284, Exp 05/16

Lot Numbers:
7801273

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71004
Status: Resolved
Manufacturer: Mylan Institutional LLC
Manufactured In: United States
Units Affected: 3 products (a) 35,197 vials; b) 21,302 vials; 2,455 vials; 10,094 vials)

Were You Affected by This Recall?

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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.