Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack Kit
FDA Recall NDC 69676-0079
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Maximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack (NDC 69676-0079). A significant event, classified as Class III, was initiated on Sep 25, 2024 by Genexa Inc.. The reported reason for this action was: "Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Sep 25, 2024
Nov 13, 2024
72,648 bottles
Recall Profile & Regulatory Data
Event ID
95430
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Denison Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
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
Batch or Lot Expiration Information
Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
Affected Packages Involved in this Recall
69676-0079-3Product
69676-0077-9Product
69676-0094-9Product
8500157361Product
Class III Ongoing
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Sep 25, 2024
Nov 13, 2024
105,048 bottles
Recall Profile & Regulatory Data
Event ID
95430
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Denison Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Product Description
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
Affected Packages Involved in this Recall
69676-0079-3Product
69676-0077-9Product
69676-0094-9Product
8500157360Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
