Class III
Ongoing
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
This recall is currently active, issued November 13, 2024. It was issued by Denison Pharmaceuticals, Llc.
- Company
- Denison Pharmaceuticals, Llc
- Recall Initiated
- September 25, 2024
- Posted
- November 13, 2024
- Recall Number
- D-0033-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 72,648 bottles
- Firm Location
- Lincoln, RI, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
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