Topiramate 25mg Tabs White/round tablets recalled over manufacturing violations
- Recall date
- July 27, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Calvin Scott & Company, Inc. recalls Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg:…
- Recall number
- D-1520-2020
- FDA classification
- Class II
- Brand / firm
- Calvin Scott & Company, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
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