Ibuprofen Tablets recalled over manufacturing violations

Recall date

January 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (N…

Recall number

D-0685-2018

FDA classification

Class II

Brand / firm

Time-Cap Laboratories, Inc.

Sold / distributed

Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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