Ibuprofen Tablet, Film Coated
FDA Recall NDC 49483-604

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Ibuprofen (NDC 49483-604). 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.

Reported Recall Events

D-0687-2018TERMINATEDD-0692-2018TERMINATEDD-0689-2018TERMINATEDD-1055-2017TERMINATED

January 2018 Class II Recall: CGMP Deviations

Recall Number
D-0687-2018
Class II Terminated
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Initiated
Jan 11, 2018
Reported
May 02, 2018
Quantity
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 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Batch or Lot Expiration Information
Lot# a) M104C, exp 9/18, L016C, H092C, and H093C, exp 9/18 b) C128C, C129C, C130C, C132C, exp 3/18, HK6011, exp 7/18, L016C and H092C, exp 9/18
Affected Packages Involved in this Recall
49483-602-01Product
49483-602-50Product
49483-603-03Product
49483-603-50Product
49483-603-05Product
49483-603-01Product
49483-604-01Product
49483-604-50Product
49483-604-05Product
49483-604-03Product

January 2018 Class II Recall: CGMP Deviations

Recall Number
D-0692-2018
Class II Terminated
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Initiated
Jan 11, 2018
Reported
May 02, 2018
Quantity
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 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Batch or Lot Expiration Information
Lot# a) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M105C, L017C, L018C, L019C, L020C, L021C, L022C, exp 9/18
Affected Packages Involved in this Recall
49483-602-01Product
49483-602-50Product
49483-603-03Product
49483-603-50Product
49483-603-05Product
49483-603-01Product
49483-604-01Product
49483-604-50Product
49483-604-05Product
49483-604-03Product

January 2018 Class II Recall: CGMP Deviations

Recall Number
D-0689-2018
Class II Terminated
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Initiated
Jan 11, 2018
Reported
May 02, 2018
Quantity
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 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
Batch or Lot Expiration Information
Lot# a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18
Affected Packages Involved in this Recall
49483-602-01Product
49483-602-50Product
49483-603-03Product
49483-603-50Product
49483-603-05Product
49483-603-01Product
49483-604-01Product
49483-604-50Product
49483-604-05Product
49483-604-03Product

June 2017 Class II Recall: Presence of foreign tablets/capsules

Recall Number
D-1055-2017
Class II Terminated
Reason for Recall
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Initiated
Jun 16, 2017
Reported
Aug 09, 2017
Quantity
1,980 bottles

Recall Profile & Regulatory Data

Event ID
77576
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Time-Cap Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide U.S.A.
Termination Date
May 29, 2020
Product Description
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50
Batch or Lot Expiration Information
Lot# : HN7003
Affected Packages Involved in this Recall
49483-602-01Product
49483-602-50Product
49483-603-03Product
49483-603-50Product
49483-603-05Product
49483-603-01Product
49483-604-01Product
49483-604-50Product
49483-604-05Product
49483-604-03Product

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.