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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

Golden State Medical Supply Inc.: Failed Impurities/Degradation Specifications: Out of specification for impurities.

Agency Publication Date: December 4, 2015
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Affected Products

Product: MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10.

Lot # GS007205 Expiry: Aug-17; Lot #:GS007344, Expiry: Aug-17; Lot #: GS008089, Expiry: Feb-18; Lot #: GS008842, Expiry: Feb-18; Lot #: GS009055, Expiry: Feb-18; Lot #: GS009131; Expiry: Feb-18.

Lot Numbers:
GS007205
GS007344
GS008089
GS008842
GS009055
GS009131
Product: MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.

a) Lot #: GS005224, Expiry: Jul-16, Lot:#: GS007553, Expiry: Nov-17; Lot #: GS007858, Expiry: Nov-17. b) Lot #: GS002674, Expiry: Jan-16; Lot #: GS003402, Expiry:May-16; Lot #: GS003582, Expiry: Jun-16; Lot #: GS004899, Expiry: Jun-16; Lot #: GS005908, Expiry: Jun-17; Lot #: GS006088, Expiry: Jun-17; Lot #: GS006254, Expiry: Sep-17; Lot #: GS007345, Expiry: Nov-17; Lot #: GS007664, Expiry: Nov-17; Lot #: GS007803, Expiry: Nov-17; Lot #: GS008091, Expiry: Nov-17.

Lot Numbers:
GS005224
GS007553
GS007858
GS002674
GS003402
GS003582
GS004899
GS005908
GS006088
GS006254
GS007345
GS007664
GS007803
GS008091

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72733
Status: Resolved
Manufacturer: Golden State Medical Supply Inc.
Manufactured In: United States
Units Affected: 2 products (1136 Bottles; a) 737 Bottles; b) 3863 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.