Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packag...
FDA Recall #D-0034-2025 — Class III — September 25, 2024
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
Reason for Recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recalling Firm
Denison Pharmaceuticals, LLC — Lincoln, RI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
105,048 bottles
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Code Information
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated