FDA recall D-0409-2015

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.

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-0409-2015