FDA recall D-0407-2015

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2014-12-04

Report date

2015-03-18

Termination date

2018-04-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2015