Exact FDA event identifier

Event 79349

11 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 11, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Time-Cap Laboratories, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

11 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 11

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

D-0685-2018

Recall number: D-0685-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

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

Distribution pattern

Nationwide.

drug · product 2 of 11

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

D-0686-2018

Recall number: D-0686-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) D167C, exp 2/18, E135C, exp 3/18; b) D172C, exp 2/18; c) D167C, exp 2/18, E135C, exp 3/18

Distribution pattern

Nationwide.

drug · product 3 of 11

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

D-0687-2018

Recall number: D-0687-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

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,

Distribution pattern

Nationwide.

drug · product 4 of 11

Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

D-0688-2018

Recall number: D-0688-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

C128C, C129C, exp 3/18

Distribution pattern

Nationwide.

drug · product 5 of 11

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

D-0689-2018

Recall number: D-0689-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

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

Distribution pattern

Nationwide.

drug · product 6 of 11

Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

D-0690-2018

Recall number: D-0690-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) D044C, D038C, D043C, exp 3/18, b) C136C, exp 3/18, D039C, D040C, D041C, D042C, 3/18

Distribution pattern

Nationwide.

drug · product 7 of 11

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

D-0691-2018

Recall number: D-0691-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) C135C, exp 3/18 b) C134C, exp 3/18

Distribution pattern

Nationwide.

drug · product 8 of 11

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

D-0692-2018

Recall number: D-0692-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

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

Distribution pattern

Nationwide.

drug · product 9 of 11

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

D-0693-2018

Recall number: D-0693-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) C140C, exp 2/18; b) D049C, D050C, D051C, C142C, C137C, C138C, C141C, exp 2/18; D073C, D074C, exp 3/18

Distribution pattern

Nationwide.

drug · product 10 of 11

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

D-0694-2018

Recall number: D-0694-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) F066C b) F066C c) F066C

Distribution pattern

Nationwide.

drug · product 11 of 11

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

D-0695-2018

Recall number: D-0695-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Time-Cap Laboratories, Inc.
Quantity: N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Code information

a) F066C b) F066C c) F066C

Distribution pattern

Nationwide.