Recalls / Class II
Class IID-1532-2020
Product
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
- Affected lot / code info
- Lot #: a) 19271, Exp. Date 10/20 b) 19206, 19209B, Exp. Date 08/20; 19229, Exp. Date 10/20; 19255, Exp. Date 09/20; 19271, Exp. Date 08/20; 19301, Exp. Date 10/20; 19327, Exp. Date 11/20; 19336, Exp. 12/20; 20012, Exp. Date 1/21; 20045, Exp. Date 2/21.
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-1532-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.