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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

Gyma Laboratories Of Amer,Inc: cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Agency Publication Date: October 10, 2014
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Affected Products

Product: Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Lot Number: 161600, Exp 03/2016

Lot Numbers:
Number
Product: Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004

Lot Number: 154919, Exp 11/2014

Lot Numbers:
Number
Product: Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01

Lot Numbers: 166247, 166248, Exp 10/2016

Lot Numbers:
Numbers
Product: Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002

Lot Numbers: 167219, 163367, 167220, 167221, Exp 03/2017

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69243
Status: Resolved
Manufacturer: Gyma Laboratories Of Amer,Inc
Manufactured In: United States
Units Affected: 4 products (10 Kg; 1 Kg; 55.8 Kg; 97 Kg)

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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.