FDA-Drug2024-11-13Class III
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
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
105,048 bottles
Manufactured in
1 Powder Hill Rd, N/A, Lincoln, RI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2025Don't want to check this manually?
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