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
Reported: February 26, 2025 Initiated: February 4, 2025 #D-0229-2025
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%)
Details
- Recalling Firm
- AvKARE
- Units Affected
- 1266 bottles
- Distribution
- USA Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AvKARE. Units affected: 1266 bottles.
Why was this product recalled? ▼
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%)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 26, 2025. Severity: Moderate. Recall number: D-0229-2025.
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