Ibuprofen Tablet, Film Coated
FDA Recall NDC 49483-601
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 Ibuprofen (NDC 49483-601). A significant event, classified as Class II, was initiated on Jan 11, 2018 by Time Cap Laboratories,inc. 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 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Batch or Lot Expiration Information
Lot# a) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18
Affected Packages Involved in this Recall
49483-114-50Product
49483-114-10Product
49483-114-17Product
49483-114-73Product
49483-601-00Product
49483-601-05Product
49483-601-01Product
49483-601-50Product
49483-601-10Product
49483-600-05Product
49483-600-01Product
49483-600-50Product
49489-601-10Product
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 Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Batch or Lot Expiration Information
Lot# a) F066C b) F066C c) F066C
Affected Packages Involved in this Recall
49483-114-50Product
49483-114-10Product
49483-114-17Product
49483-114-73Product
49483-601-00Product
49483-601-05Product
49483-601-01Product
49483-601-50Product
49483-601-10Product
49483-600-05Product
49483-600-01Product
49483-600-50Product
49483-600-00Product
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.
