Drug product
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
D-0034-2025
Product summary
- Event
- Event 95430
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 105,048 bottles
- Official record key
drug-enforcement:D-0034-2025
Official wording
Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Code information: Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
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.