Micro Labs Usa, Inc S recalls Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only,…

Recall date

December 4, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0407-2015

FDA classification

Class III

Brand / firm

Micro Labs Usa, Inc S

Sold / distributed

Nationwide.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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