D-1515-2020 Class II Terminated
FDA drug recall D-1515-2020 was initiated by Calvin Scott & Company, Inc. on July 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 April 11, 2024). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2020
- Initiation Date
- July 27, 2020
- Termination Date
- April 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
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 #: 19260H; Exp. Date: 1/21