RecallRadar

FDA Drug recall D-0237-2018

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…

On 2018-01-31 the FDA classified a Class II recall of Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by… by Marksans Pharma, citing CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0237-2018
ClassificationClass II
Statusterminated
Initiated2018-01-09
Published2018-01-31
Last updated2026-09-13 11:52 UTC
CompanyMarksans Pharma
DistributionUS

Product

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.

Reason

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

Identifiers

ndc25000-114-03
ndc25000-114-14
ndc25000-114-20
ndc25000-114-30
ndc25000-114-98
ndc25000-114-93
ndc25000-114-70
ndc25000-114-71
ndc25000-114-02
ndc25000-117-03
ndc25000-117-14
ndc25000-117-20
ndc25000-117-30
ndc25000-117-98
ndc25000-117-93
ndc25000-117-69
ndc25000-117-02
code_info
Lot #: HJ6080, HJ6081, HJ6082, HJ6083, HJ6084, HJ6085, HJ6086, HJ6087, HJ6088, HJ6089, HJ6090, HJ6091, HJ6092, HJ6093,…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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0237-2018%22

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