Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed
Summary
The FDA issued a Class III for Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 C by LNK International, Inc.. Reason: Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coa.
Details
Source
Drug Recall
External ID
D-0665-2021
Action Date
2021-07-28
Status
Terminated
Category
drug
Product Description
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71
Lot/Code Info: Lot # P120999, Exp 07/31/2022
Quantity Affected: 8,472 bottles
Reason for Recall
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Distribution
Distributed in PA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-07
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 49 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-0665-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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