AVKARE Inc. recalls Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski,…
- Recall date
- February 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0610-2017
- FDA classification
- Class II
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
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