Why it was recalled
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Product description
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, 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 #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
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-246-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 12, 2013
- FDA report date
- Apr 17, 2013
- Quantity
- 71,893 dispensers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-246-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64607
- Address
- 650 Cathill Rd
- Code information
- Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
- Postal code
- 18960-1512
- Report date
- Apr 17, 2013
- Product type
- Drugs
- Recall number
- D-246-2013
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 71,893 dispensers
- Termination date
- Jan 15, 2014
- Reason for recall
- Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, 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
- Mar 12, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 10, 2013