Ibuprofen Tablet, Film Coated
FDA Recall NDC 53943-291
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 Ibuprofen (NDC 53943-291). A significant event, classified as Class II, was initiated on Jan 11, 2018 by Discount Drug Mart. The reported reason for this action was: "CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies."
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
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Jan 11, 2018
May 02, 2018
N/A
Recall Profile & Regulatory Data
Event ID
79349
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Time-Cap Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jan 20, 2021
Product Description
Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Batch or Lot Expiration Information
Lot# a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18
Affected Packages Involved in this Recall
53943-291-15Product
53943-291-12Product
53943-291-14Product
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.
