D-1528-2020 Class II Terminated
FDA drug recall D-1528-2020 was initiated by Calvin Scott & Company, Inc. on Jul 27, 2020 and is designated Class II. Reason for recall: CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. The recall status is terminated (terminated Apr 11, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 26, 2020
- Initiation Date
- Jul 27, 2020
- Termination Date
- Apr 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC 10702-0028-10), b) 28-count bags (NDC 10702-0028-10) and c) 56-count bags (NDC 10702-0028-10), Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by KVK-Tech Newtown, PA 18940; NDC 10702-0028-10
Reason for Recall
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a)19290, Exp. Date: 10/20; b) 19224; Exp. Date: 08/20; 19249, Exp. Date: 09/20; 19290, Exp. Date: 10/20; 19322, Exp. Date: 12/20; 20013, Exp. Date: 01/21; 20039, Exp. Date: 02/21 c) 19290, Exp. Date: 10/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1528-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026