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Recall Observatory FDA recall evidence

Drug 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.

D-1472-2022

August 04, 2022

Class III

Product summary

Firm
LNK International, Inc.
Event
Event 90708
Status
Terminated
Classification
Class III
Quantity
257,064 cartons
Official record key
drug-enforcement:D-1472-2022

Official wording

Reason: Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

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

Distribution pattern: Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.