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.
FDA recall notice · announced March 18, 2015 · Micro Labs Usa, Inc S
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The product
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.
Reason for recall
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Notes
Distribution: Nationwide.
Lot/code information: Lot #: STDG010, Exp 3/2015
Quantity: 13488 bottles
Status: Terminated
Products in this recall event:
- 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 L (D-0407-2015)
- 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. (D-0409-2015)
- 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. (D-0408-2015)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.