AVKARE Inc. recalls Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 3…
- Recall date
- January 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0222-2018
- FDA classification
- Class II
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
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