Reported Feb 26, 2025 · Ongoing
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal…
AvKARE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AvKARE · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- Silodosin Capsules, 8mg, 90-count bottle, Rx only
- Manufactured forAvKare, Pulaski, TN 38478
- Manufactured byAmneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
- Lot codes and dates
Lot#: BC20223AExp. March 312025
- Amount recalled
- 1266 bottles
Where it was sold
- Nationwide
Why it was 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%)
This product could cause temporary or reversible health problems — stop using it.
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