Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Reported: November 13, 2024 Initiated: September 25, 2024 #D-0033-2025
Product Description
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
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
- 72,648 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? ▼
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155. Recalled by Denison Pharmaceuticals, LLC. Units affected: 72,648 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-0033-2025.
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