Methylphenidate hydrochloride Extended-Release ablets USP recalled over manufacturing violations

Recall date

January 27, 2020

Source

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

Official notice title

Teva Pharmaceuticals USA recalls Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals…

Recall number

D-0837-2020

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

USA Nationwide

Why it was recalled

CGMP deviations: Product bottle may be absent of desiccant.

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

What was recalled

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01