FDADecember 4, 2014drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

What to do

FDA enforcement status: Terminated

Brands named

micro labs usa inc smicromicro labs

UPCs

4251700201042571002010

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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