Teva Pharmaceuticals USA recalls Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottle…

Recall date

January 28, 2020

Source

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

Recall number

D-0851-2020

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

U.S.A. Nationwide

Why it was recalled

Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545