Status
Ongoing
Drug Enforcement D-0033-2025
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Classification
Class III
Report Date
November 13, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 72,648 bottles
- Reason for recall
- Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Location & Firm
- Recalling firm
- Denison Pharmaceuticals, LLC
- Address
-
1 Powder Hill Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0033-2025
- Event ID
- 95430
- Recall initiation date
- September 25, 2024
- Center classification date
- November 1, 2024
- Code info
- Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
- More code info
- —