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.
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
Lot numbers, UPCs & expiration codes
LF01215A, Exp 02/2014
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-152-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 22, 2013
- FDA report date
- Feb 13, 2013
- Quantity
- 17,188 cartons containing 3 cards each.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-152-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 64118
- Address
- 2555 W Midway Blvd
- Code information
- LF01215A, Exp 02/2014
- Postal code
- 80020-1632
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-152-2013
- Classification
- Class III
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 17,188 cartons containing 3 cards each.
- Termination date
- May 7, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2013