FDA-Drug2015-03-18Class III

Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

Micro Labs Usa, Inc S
Hazard

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

Sold states
Nationwide.
Affected count
13488 bottles
Manufactured in
104 Carnegie Ctr, Te 216, Princeton, NJ, United States
Products
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0408-2015

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