Drug product
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
D-0817-2016
Product summary
- Firm
- Biocon Inc
- Event
- Event 73699
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5505 bottles
- Official record key
drug-enforcement:D-0817-2016
Official wording
Reason: Subpotent Drug
Code information: Lot # 14S0042F5B, exp. 4/2016
Distribution pattern: PA, CA, & OH
Derived failure modes
-
Potency or specification failure
Subpotent