Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur
Recalled November 13, 2024 · FDA recall D-0033-2025 · Denison Pharmaceuticals
Hazard
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. · FDA Class III
Units
72,648 bottles
Sold at
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Description
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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
Manufacturer(s)
Denison Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →