Acetaminophen Tablet
FDA Recall NDC 0904-6730
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 Acetaminophen (NDC 0904-6730). A significant event, classified as Class II, was initiated on May 20, 2024 by Major Pharmaceuticals. The reported reason for this action was: "Discoloration: Brownish tablets"
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 II Ongoing
Discoloration: Brownish tablets
May 20, 2024
Jul 03, 2024
14,616 bottles
Recall Profile & Regulatory Data
Event ID
94675
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Contract Pharmacal Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MI
Product Description
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
Batch or Lot Expiration Information
Lot# : 368638; Exp. 05/2025
Affected Packages Involved in this Recall
0904-6730-60Product
0904-6730-80Product
0904-6730-59Product
0904-6730-61Product
3090467306Product
Class II Terminated
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Feb 03, 2020
Feb 19, 2020
a) 1176 bottles b) 6,216 bottles
Recall Profile & Regulatory Data
Event ID
84857
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Contract Pharmacal Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 22, 2024
Product Description
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA
Batch or Lot Expiration Information
Lot# : 193005, Exp. Date 08/21
Affected Packages Involved in this Recall
0904-6730-60Product
0904-6730-80Product
0904-6730-59Product
0904-6730-61Product
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.
