Drug recall D-0033-2025
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.
Lots and codes
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Recall details
- Recalling firm
- Denison Pharmaceuticals, LLC, Lincoln, RI
- Quantity
- 72,648 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.