Why it was recalled
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Product description
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Lot numbers, UPCs & expiration codes
Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
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-1384-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 23, 2012
- FDA report date
- Jun 27, 2012
- Quantity
- 40,750 Dispensers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1384-2012, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61759
- Address
- 650 Cathill Rd
- Code information
- Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013
- Postal code
- 18960-1512
- Report date
- Jun 27, 2012
- Product type
- Drugs
- Recall number
- D-1384-2012
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 40,750 Dispensers
- Termination date
- Apr 23, 2013
- Reason for recall
- Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 23, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 19, 2012