FDAFDA · Food and drugs·Recall number 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-69676-0077-9, UPC Code# 850015736018
Published November 13, 2024 · Recall initiated: September 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK
- Manufacturer
- Denison Pharmaceuticals, LLC
- Distributor
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- UPC
- 850015736018
- Lot
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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