NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRE
Summary
The FDA issued a Class III for NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN REL by LNK International, Inc.. Reason: Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg.
Details
Source
Drug Recall
External ID
D-0014-2023
Action Date
2022-10-26
Status
Terminated
Category
drug
Product Description
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Lot/Code Info: P129910 P129911 P130240
Quantity Affected: 66,384 boxes of twenty tablets each
Reason for Recall
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-11
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 16 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-0014-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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