Exact FDA event identifier

Event 78822

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

Event summary

Timeline bucket: January 09, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Marksans Pharma 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

6 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 6

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.

D-0235-2018

Recall number: D-0235-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 2,853,500 Caplets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: HH6001, HH6002, Exp 04/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

drug · product 2 of 6

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20.

D-0236-2018

Recall number: D-0236-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 4,127,500 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: HI6001, HI6002, HI6003, Exp 02/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

drug · product 3 of 6

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.

D-0237-2018

Recall number: D-0237-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 205,088,000 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: HJ6080, HJ6081, HJ6082, HJ6083, HJ6084, HJ6085, HJ6086, HJ6087, HJ6088, HJ6089, HJ6090, HJ6091, HJ6092, HJ6093, HJ6094, HJ6095, HJ6096, HJ6097, HJ6098, HJ6099, HJ6100, HJ6101, HJ6102, HJ6103, HJ6104, HJ6105, HJ6106, HJ6107, HJ6108, HJ6109, HJ6110, HJ6111, HJ6112, Exp 02/18; HJ6113, HJ6114, HJ6115, HJ6116, HJ6117, HJ6118, HJ6119, HJ6120, HJ6121, HJ6122, HJ6123, HJ6124, HJ6125, HJ6126, HJ6127, HJ6128, HJ6129, HJ6130, HJ6131, HJ6132, HJ6133, HJ6134, HJ6135, HJ6136, Exp 03/18; HJ6137, HJ6138, HJ6139, HJ6140, HJ6141, HJ6142, HJ6143, HJ6144, HJ6145, HJ6146, HJ6147, HJ6148, HJ6149, HJ6150, HJ6151, HJ6152, HJ6143, HJ6154, HJ6155, HJ6156, HJ6157, HJ6158, HJ6159, HJ6160, HJ6161, HJ6162, HJ6163, HJ6164, HJ6165, HJ6166, HJ6167, HJ6168, HJ6169, HJ6180, HJ6171, HJ6172, HJ6173, HJ6174, HJ6175, Exp 04/18; HJ6176, HJ6177, HJ6178, HJ6179, HJ6180, HJ6181, HJ6182, HJ6183, HJ6184, HJ6185, HJ6186, HJ6187, HJ6188, HJ6189, HJ6190, HJ6191, HJ6192, HJ6193, HJ6194, HJ6195, HJ6196, HJ6197, HJ6198, HJ6199, HJ6200, HJ6201, HJ6202, HJ6203, Exp 05/18; HJ6204, HJ6025, HJ6206, HJ6207, HJ6208, HJ6209, HJ6210, HJ6211, HJ6212, HJ6213, HJ6214, HJ6215, Exp 06/18; HJ6216, HJ6217, HJ6218, HJ6219, HJ6220, Exp 08/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

drug · product 4 of 6

Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29.

D-0238-2018

Recall number: D-0238-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 21,584,100 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

drug · product 5 of 6

Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.

D-0239-2018

Recall number: D-0239-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 23,088,900 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, HN6014, Exp 03/18; HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, HN6023, Exp 04/18; HN6024, Exp 07/18; HN6025, HN6026, HN6027, Exp 09/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

drug · product 6 of 6

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27.

D-0240-2018

Recall number: D-0240-2018
Initiated: January 09, 2018
Classification: Class II
Status: Terminated
Recalling firm: Marksans Pharma Inc.
Quantity: 52,549,000 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP Deviations

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

Lot #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, HM6096, Exp 02/18; HM6097, HM6098, HM6099, Exp 03/18; HM6100, HM6101, HM6102, HM6103, HM6104, HM6105, HM6106, HM6107, HM6108, HM6109, HM6110, HM6111, HM6112, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, HM6119, HM6120, HM6121, HM6122, HM6123, HM6124, HM6125, HM6126, HM6127, HM6128, HM6129, HM6130, HM6131, HM6132, Exp 08/18; HM6133, HM6134, HM6135, HM6136, HM6137, HM6128, HM6139; Exp 09/18

Distribution pattern

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.