Why it was recalled
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Product description
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Lot numbers, UPCs & expiration codes
Lot: LF01213A, Exp. 02/14
Where it was sold
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
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-805-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 21, 2013
- FDA report date
- Jul 24, 2013
- Quantity
- 10,848 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-805-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 65511
- Address
- 2555 W Midway Blvd
- Code information
- Lot: LF01213A, Exp. 02/14
- Postal code
- 80020-1632
- Report date
- Jul 24, 2013
- Product type
- Drugs
- Recall number
- D-805-2013
- Classification
- Class II
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 10,848 cartons
- Termination date
- Jan 29, 2014
- Reason for recall
- Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
- Distribution pattern
- Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
- Recall initiation date
- Jun 21, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2013