Drug 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
D-0407-2015
Product summary
- Event
- Event 69928
- Status
- Terminated
- Classification
- Class III
- Quantity
- 240 (1000-count bottle), 26,904 (90-count bottle)
- Official record key
drug-enforcement:D-0407-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Code information: Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications