FDA-Drug2024-11-13Class III
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
Denison Pharmaceuticals, LLC
Hazard
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Sold states
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Affected count
72,648 bottles
Manufactured in
1 Powder Hill Rd, N/A, Lincoln, RI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2025Don't want to check this manually?
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