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
105,048 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
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
Code / lot info
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
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.