FDAHealthFebruary 4, 2025
AvKARE — 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
⚠️ 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%)
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 4, 2025
USA Nationwide
What's affected?
- 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
- Brand
- SILODOSIN
- Lot code
- BC20223A
Additional details
Lot#: BC20223A, Exp. March 31, 2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1266 bottles.
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