D-1472-2022 Class III Terminated
FDA drug recall D-1472-2022 was initiated by LNK International, Inc. on Aug 4, 2022 and is designated Class III. Reason for recall: Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate. The recall status is terminated (terminated Mar 3, 2023). Affected quantity: 257,064 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 7, 2022
- Initiation Date
- Aug 4, 2022
- Termination Date
- Mar 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257,064 cartons
Product Description
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Reason for Recall
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Distribution Pattern
Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
Code Information
P121512, exp. date 08/2023; P122015, exp. date 09/2023; P122712, exp. date 11/2023; P123090, exp. date 12/2023; P123170, exp. date 12/2023; P124325, exp. date 03/2024; P124664, exp. date 03/2024; P125165, exp. date 05/2024; P125576, exp. date 06/2024; P125577, exp. date 06/2024; P127089, exp. date 10/2024; P127090, exp. date 10/2024; P127386, exp. date 11/2024; P128572, exp. date 01/2025; P128383, exp. date 01/2025; P129536, exp. date 04/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1472-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026