Drug Recall: Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-696
Denison Pharmaceuticals, LLC · September 25, 2024
Reason for Recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Product Description
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Quantity Affected
72,648 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0033-2025
Status: ongoing
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