FDA-Drug2018-01-31Class II
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.
Marksans Pharma Inc.
Hazard
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Sold states
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Affected count
23,088,900 tablets
Manufactured in
Suite # 401, 4th Floor, Room No. 430, 150 Motor Parkway, Hauppauge, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0239-2018Don't want to check this manually?
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