Recalls / Class III
Class IIID-1472-2022
Product
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.
- Affected lot / code info
- 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
Why it was recalled
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Recalling firm
- Firm
- LNK International, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 55 Arkay Dr, Hauppauge, New York 11788-3707
Distribution
- Quantity
- 257,064 cartons
- Distribution pattern
- Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
Timeline
- Recall initiated
- 2022-08-04
- FDA classified
- 2022-08-30
- Posted by FDA
- 2022-09-07
- Terminated
- 2023-03-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1472-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.