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

Recall Number: D-0407-2015

Firm: Micro Labs Usa, Inc S

Classification: Class III

Status: Terminated

Report Date: 20150318

Initiation Date: 20141204

Termination Date: 20180425

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

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