FDA recall D-0856-2020

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

Reason for recall

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.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-02-12

Report date

2020-03-04

Termination date

2023-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2020