Ibuprofen Caplets USP 200 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 Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC…

Recall number

D-0694-2018

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 Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India