FDA recall D-0033-2025

Denison Pharmaceuticals, LLC · Class III · drug

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.

Distribution

Product was distributed to two accounts that may have distributed the product further to the Retail Level.

Key facts

Status
Ongoing
Initiation date
2024-09-25
Report date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2025