FDA-Drug2018-05-02Class II
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Time-Cap Laboratories, Inc.
Hazard
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Sold states
Nationwide.
Affected count
N/A
Manufactured in
7 Michael Ave, N/A, Farmingdale, NY, United States
Products
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0685-2018Don't want to check this manually?
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