FDA recall D-152-2013

Product

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

Reason for recall

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-22

Report date

2013-02-13

Termination date

2013-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-152-2013