Broncochem Granule, For Solution
FDA Recall NDC 65131-097
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Broncochem (NDC 65131-097). A significant event, classified as Class II, was initiated on Feb 16, 2024 by Laboratorio Magnachem International Srl. The reported reason for this action was: "Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate."
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
February 2024 Class II Recall: Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Recall Number
Class II Ongoing
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Feb 16, 2024
Mar 20, 2024
2345 boxes
Recall Profile & Regulatory Data
Event ID
94015
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Global Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
Batch or Lot Expiration Information
Lot# : 123255, 123256, Exp. Date 11/2024; 123637, Exp. Date 03/2025
Affected Packages Involved in this Recall
65131-097-52Product
65131-097-53Product
65131-097-12Product
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.
