Drug product
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
D-0229-2025
Product summary
- Firm
- AvKARE
- Event
- Event 96247
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1266 bottles
- Official record key
drug-enforcement:D-0229-2025
Official wording
Reason: Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Code information: Lot#: BC20223A, Exp. March 31, 2025.
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent