Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, M...
FDA Recall #D-0229-2025 — Class II — February 4, 2025
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%)
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1266 bottles
Distribution
USA Nationwide
Code Information
Lot#: BC20223A, Exp. March 31, 2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated