Class II
Ongoing
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
- Company
- Avkare
- Recall Initiated
- February 4, 2025
- Posted
- February 26, 2025
- Recall Number
- D-0229-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1266 bottles
- Firm Location
- Pulaski, TN, United States
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
USA Nationwide
Lot / Code Info
Lot#: BC20223A, Exp. March 31, 2025.
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