Drug product
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
Product summary
- Event
- Event 69928
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13464 bottles
- Official record key
drug-enforcement:D-0409-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Code information: Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications