Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd.
Summary
The FDA issued a Class III for Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Dis by AptaPharma Inc.. Reason: Incorrect/Undeclared Excipient: Product contains alcohol.
Details
Source
Drug Recall
External ID
D-0787-2022
Action Date
2022-05-04
Status
Terminated
Category
drug
Product Description
Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
Lot/Code Info: All lots
Quantity Affected: 40000 - 50000 units
Reason for Recall
Incorrect/Undeclared Excipient: Product contains alcohol
Distribution
IL only
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-29
Company
Pennsauken, NJ
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 121 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (AptaPharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AptaPharma Inc. have FDA actions?
This is the only FDA action we have on record for AptaPharma Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0787-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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