FDAFebruary 12, 2020drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

golden state medical supplygoldengolden state

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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