Recalls / Class III
Class IIID-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
- Affected lot / code info
- LF01215A, Exp 02/2014
Why it was 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.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 17,188 cartons containing 3 cards each.
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-22
- FDA classified
- 2013-02-06
- Posted by FDA
- 2013-02-13
- Terminated
- 2013-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-152-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.