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Recall Observatory FDA recall evidence

Drug product

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

D-0033-2025

September 25, 2024

Class III

Product summary

Firm
Denison Pharmaceuticals, LLC
Event
Event 95430
Status
Ongoing
Classification
Class III
Quantity
72,648 bottles
Official record key
drug-enforcement:D-0033-2025

Official wording

Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Code information: Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024

Distribution pattern: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.