D-0034-2025 Class III Ongoing
FDA drug recall D-0034-2025 was initiated by Denison Pharmaceuticals, LLC on September 25, 2024 and is designated Class III. Reason for recall: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. The recall status is ongoing. Affected quantity: 105,048 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2024
- Initiation Date
- September 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,048 bottles
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.
Distribution Pattern
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Code Information
Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025