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Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packa...

FDA Recall #D-0033-2025 — Class III — September 25, 2024

Recall #D-0033-2025 Date: September 25, 2024 Classification: Class III Status: Ongoing

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.

Recalling Firm

Denison Pharmaceuticals, LLC — Lincoln, RI

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

72,648 bottles

Distribution

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

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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