Recalling firm
Denison Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2024-11-13
Distribution
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Firm state
RI
Product quantity
72,648 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Product description
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
Code / lot info
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.