Drug recall D-0229-2025

Class II Ongoing reported Feb 26, 2025

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

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%)

Lots and codes

Lot#: BC20223A, Exp. March 31, 2025.

Recall details

Recalling firm
AvKARE, Pulaski, TN
Quantity
1266 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 4, 2025

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