Ibuprofen Tablets recalled over manufacturing violations

Recall date

January 9, 2018

Source

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

Official notice title

Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx o…

Recall number

D-0239-2018

FDA classification

Class II

Brand / firm

Marksans Pharma Inc.

Sold / distributed

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

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, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28.