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Recall Observatory FDA recall evidence

Drug product

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

D-0034-2025

September 25, 2024

Class III

Product summary

Firm
Denison Pharmaceuticals, LLC
Event
Event 95430
Status
Ongoing
Classification
Class III
Quantity
105,048 bottles
Official record key
drug-enforcement:D-0034-2025

Official wording

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

Code information: Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025

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.