D-0229-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2025
- Initiation Date
- February 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1266 bottles
Product Description
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
Reason for Recall
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%)
Distribution Pattern
USA Nationwide
Code Information
Lot#: BC20223A, Exp. March 31, 2025.