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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

Micro Labs Usa, Inc S: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

Agency Publication Date: March 11, 2015
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Affected Products

Product: Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540

Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.

Lot Numbers:
STCG005
STCG011
STCG012
Product: Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

Lot #: STDG010, Exp 3/2015

Lot Numbers:
STDG010
Product: Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.

Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015

Lot Numbers:
STEG004
STEG006

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 69928
Status: Resolved
Manufacturer: Micro Labs Usa, Inc S
Manufactured In: United States
Units Affected: 3 products (240 (1000-count bottle), 26,904 (90-count bottle); 13488 bottles; 13464 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.