Ibuprofen Tablets USP 600 mg 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 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufa…

Recall number

D-0689-2018

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 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India