Recalls / Class II
Class IID-0240-2018
Product
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.
- Affected lot / code info
- 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
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.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Suite # 401, 4th Floor, Room No. 430, 150 Motor Parkway, Hauppauge, New York 11788
Distribution
- Quantity
- 52,549,000 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-0240-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.