Drug product
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
D-0246-2015
Product summary
- Event
- Event 69268
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,008 bottles
- Official record key
drug-enforcement:D-0246-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Code information: Lot #: STBG005, Exp 2/2015
Distribution pattern: NY
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications