Ibuprofen Tablets USP 400 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 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International…

Recall number

D-0688-2018

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 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India