Multi-event September 2024 FDA Recall Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack by Denison Pharmaceuticals, Llc
This Multi-event Class III drug recall was voluntarily initiated by Denison Pharmaceuticals, Llc on September 25, 2024 for the product Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack. The FDA reported the reason for recall as crystallization. The product was distributed in Product was distributed to two accounts that may have distributed the product further to the Retail Level. and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0033-2025
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
09-25-2024
11-13-2024
72,648 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Denison Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Affected Packages Involved in this Recall
Recall Number: D-0034-2025
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
09-25-2024
11-13-2024
105,048 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Denison Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 0813V, Exp 06/2025; 0103V, Exp 03/2025
