FDAHealthSeptember 25, 2024
Denison Pharmaceuticals, LLC — 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 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
- 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
- UPC
- 850015736018
- Lot code
- 0813V
Additional details
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 105,048 bottles.
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