Why it was recalled
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Product description
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
Lot numbers, UPCs & expiration codes
Lots: LF01643C, LF01644C, Exp 7/14
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-854-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 7, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 8, 681 unit cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-854-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 65877
- Address
- 2555 W Midway Blvd
- Code information
- Lots: LF01643C, LF01644C, Exp 7/14
- Postal code
- 80020-1632
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-854-2013
- Classification
- Class III
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 8, 681 unit cartons
- Termination date
- Jul 7, 2014
- Reason for recall
- Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2013