Recalls / Class II
Class IID-0237-2018
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.
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 25000-114, 25000-117
- FDA application
- ANDA091239
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recalling firm
- Firm
- Marksans Pharma Inc.
- Manufacturer
- MARKSANS PHARMA LIMITED
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Suite # 401, 4th Floor, Room No. 430, 150 Motor Parkway, Hauppauge, New York 11788
Distribution
- Quantity
- 205,088,000 tablets
- Distribution pattern
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2018-01-09
- FDA classified
- 2018-01-24
- Posted by FDA
- 2018-01-31
- Terminated
- 2020-05-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0237-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.