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
D-0033-2025
Product summary
- Event
- Event 95430
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 72,648 bottles
- Official record key
drug-enforcement:D-0033-2025
Official wording
Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Code information: Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Distribution pattern: Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Derived failure modes
-
Unknown
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.