Reported Nov 13, 2024 · Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles…
Denison Pharmaceuticals, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Denison Pharmaceuticals, LLC · 1 Powder Hill Rd · Lincoln, RI · 02865-4407
Is this the product you have?
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons
- Distributed byGenexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- Lot codes and dates
Lot#: 0813VExp 06/20250103VExp 03/2025
- Amount recalled
- 105,048 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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