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
Reported: November 13, 2024 Initiated: September 25, 2024 #D-0034-2025
Product Description
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
Reason for Recall
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Details
- Recalling Firm
- Denison Pharmaceuticals, LLC
- Units Affected
- 105,048 bottles
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Location
- Lincoln, RI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Denison Pharmaceuticals, LLC. Units affected: 105,048 bottles.
Why was this product recalled? ▼
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2024. Severity: Low. Recall number: D-0034-2025.
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