Recalls / Class II
Class IID-1520-2020
Product
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
- Affected lot / code info
- Lot #: 19234; Exp. Date: 9/20
Why it was recalled
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Recalling firm
- Firm
- Calvin Scott & Company, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 209 Eubank Blvd Ne, N/A, Albuquerque, New Mexico 87123-2745
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-07-27
- FDA classified
- 2020-08-20
- Posted by FDA
- 2020-08-26
- Terminated
- 2024-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1520-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.