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 6042
Recalled March 4, 2020 · FDA recall D-0856-2020 · Golden State Medical Supply
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. · FDA Class III
Units
379,043 100-ct bottles and 330,997 500-ct bottles
Sold at
Distributed Nationwide in the USA
Description
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.
Product
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
Manufacturer(s)
Golden State Medical Supply Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →