Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmac
Summary
The FDA issued a Class III for Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters by LNK International, Inc.. Reason: Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate..
Details
Source
Drug Recall
External ID
D-1472-2022
Action Date
2022-09-07
Status
Terminated
Category
drug
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.
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
Quantity Affected: 257,064 cartons
Reason for Recall
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Distribution
Product was distributed to one retailer who may have further distributed the product to other distribution sites nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-04
Company
Hauppauge, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 133 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
LNK International, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LNK International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LNK International, Inc. have FDA actions?
LNK International, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1472-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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