Recalls / Class II
Class IID-1522-2020
Product
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
- Affected lot / code info
- a) Lot #: 19236, Exp. Date 10/20 b) Lot #: 19170; 19236, Exp. Date: 09/20; 19303, Exp. Date: 11/20; 19347, Exp. Date: 12/20; 19353, Exp. Date: 01/21: 20032, 20047, Exp. Date: 2/21. c) Lot #: 19236, Exp. Date 10/20
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-1522-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.