FDARecalled Nov 13, 2024 · #D-0034-2025
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-...
Hazard
Class III — low health risk
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Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Classification: Class III Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Denison Pharmaceuticals, LLC
- Model numbers
- 0813V
- UPCs
- —