FDAClass IIINovember 13, 2024

Kids' Cough and Chest Congestion recall

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

Why was Kids' Cough and Chest Congestion recalled?

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025

Product
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
Recalling firm
Denison Pharmaceuticals, LLC
Quantity
105,048 bottles
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Recall date
November 13, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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