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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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Low RiskFDA Drug

Shionogi Inc.: Failed Dissolution Specifications: Low dissolution results were obtained during stability testing

Agency Publication Date: July 14, 2017
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Affected Products

Product: Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30

Lot #: 5H66200103G, Exp. June 2018.

Lot Numbers:
5H66200103G
Product: PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981

Lot #: 5H66200103, Exp. June 2018

Lot Numbers:
5H66200103

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77605
Status: Resolved
Manufacturer: Shionogi Inc.
Manufactured In: United States
Units Affected: 2 products (6304 bottles; 455 bottles)

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.