FDA-Drug2015-03-18Class III
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
Micro Labs Usa, Inc S
Hazard
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Sold states
Nationwide.
Affected count
240 (1000-count bottle), 26,904 (90-count bottle)
Manufactured in
104 Carnegie Ctr, Te 216, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0407-2015Don't want to check this manually?
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