PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 13, 2013 Initiated: January 22, 2013 #D-152-2013

Product Description

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.

Details

Recalling Firm
Sandoz Incorporated
Units Affected
17,188 cartons containing 3 cards each.
Distribution
Nationwide
Location
Broomfield, CO

Frequently Asked Questions

What product was recalled?
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. Recalled by Sandoz Incorporated. Units affected: 17,188 cartons containing 3 cards each..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 13, 2013. Severity: Low. Recall number: D-152-2013.