Golden State Medical Supply Inc. recalls TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 604…

Recall date

February 12, 2020

Source

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

Recall number

D-0856-2020

FDA classification

Class III

Brand / firm

Golden State Medical Supply Inc.

Sold / distributed

Distributed Nationwide in the USA

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, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012