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

Recall Number: D-0033-2025

Firm: Denison Pharmaceuticals, LLC

Classification: Class III

Status: Ongoing

Report Date: 20241113

Initiation Date: 20240925

Termination Date:

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

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