Drug 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
D-152-2013
Product summary
- Event
- Event 64118
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,188 cartons containing 3 cards each.
- Official record key
drug-enforcement:D-152-2013
Official wording
Reason: 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.
Code information: LF01215A, Exp 02/2014
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.