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FDARecalled Nov 13, 2024 · #D-0033-2025

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-...

Hazard

Class III — low health risk

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Description

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Classification: Class III Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

Product details

Product
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
Type
Drugs
Manufacturer
Denison Pharmaceuticals, LLC
Model numbers
0104V
UPCs