D-1523-2020 Class II Terminated
FDA drug recall D-1523-2020 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
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
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 #: 19169; Exp. Date: 7/20, 08/20, 09/20; 19237, Exp. Date: 10/20, 11/20, 12/20; 19331, Exp. Date: 12/20; 20031, Exp. Date: 3/21
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1523-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026