FDAHealthSeptember 25, 2024
Denison Pharmaceuticals, LLC — 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 I
⚠️ Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- September 25, 2024
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
What's affected?
- 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
- UPC
- 850015736155
- Lot code
- 0104V
Additional details
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 72,648 bottles.
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