Drug Enforcement D-0229-2025

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%)

Status

Ongoing

Classification

Class II

Report Date

February 26, 2025

Termination Date

—

Product Information

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
Product quantity
1266 bottles
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%)
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0229-2025
Event ID
96247
Recall initiation date
February 4, 2025
Center classification date
February 20, 2025
Code info
Lot#: BC20223A, Exp. March 31, 2025.
More code info
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