Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt
Summary
The FDA issued a Class III for Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, US by Denison Pharmaceuticals, LLC. Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles..
Details
Source
Drug Recall
External ID
D-0034-2025
Action Date
2024-11-13
Status
Ongoing
Category
drug
Product Description
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Lot/Code Info: Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Quantity Affected: 105,048 bottles
Reason for Recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-25
Company
Lincoln, RI
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 35 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 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 (Denison Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Denison Pharmaceuticals, LLC have FDA actions?
Denison Pharmaceuticals, LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0034-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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