AvKARE recalls Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478.…
- Recall date
- January 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0224-2025
- FDA classification
- Class II
- Brand / firm
- AvKARE
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Out of Specification for Dissolution
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
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