Chlorpheniramine Maleate 4mg Tablet, Coated
FDA Recall NDC 53185-277
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 Chlorpheniramine Maleate 4mg (NDC 53185-277). A significant event, classified as Class II, was initiated on Oct 21, 2024 by Athlete's Needs, Inc.. The reported reason for this action was: "Superpotent Drug: Stability failure for assay at 6 months test time-point."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Oct 21, 2024
Nov 06, 2024
4,901 cases/24 count each case
Recall Profile & Regulatory Data
Event ID
95590
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BLI International, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Termination Date
Dec 05, 2025
Product Description
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
Batch or Lot Expiration Information
Lot# 24A27724, Exp 01/31/2027
Affected Packages Involved in this Recall
53185-277-24Product
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.
