FDA-Drug2013-02-13Class III

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

Sandoz Incorporated
Hazard

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.

Sold states
Nationwide
Affected count
17,188 cartons containing 3 cards each.
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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

Official notice

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

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