FDA-Drug2020-03-04Class III
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
Golden State Medical Supply Inc.
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.
Sold states
Distributed Nationwide in the USA
Affected count
379,043 100-ct bottles and 330,997 500-ct bottles
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2020Don't want to check this manually?
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