Data Composite

Recall D-0033-2025

US Class III Ongoing · initiated 2024-09-25

Recalling firm

Denison Pharmaceuticals, LLC, RI

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

Reason for recall

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

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