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Recall Observatory FDA recall evidence

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

January 22, 2013

Class III

Product summary

Firm
Sandoz Incorporated
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

    reason.no_named_rule · v1.0.0

    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.