Drug recall D-0034-2025
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
Reason for recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots and codes
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
Recall details
- Recalling firm
- Denison Pharmaceuticals, LLC, Lincoln, RI
- Quantity
- 105,048 bottles
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 25, 2024
Related products
- Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack – drug information
- NDC 69676-0079 Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack · · Genexa Inc.
- NDC 69676-0077 Cough and Chest Congestion Maximum Strength · Guaifenesin 400 mg/20mL; Dextromethorphan Hydrobromide 20… · Genexa Inc.