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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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Medium RiskFDA Drug

Mylan Institutional LLC: Lack of Assurance of Sterility; due to leaking vials

Agency Publication Date: March 23, 2015
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Affected Products

Product: Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16

Lot Numbers:
7602281
7602283
Product: Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16

Lot Numbers:
7602368
7602369

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 70564
Status: Resolved
Manufacturer: Mylan Institutional LLC
Manufactured In: United States
Units Affected: 2 products (11,030 cartons (55,150 vials); 2,523 cartons (25,936 vials))

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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.