Drug product
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.
D-246-2013
Product summary
- Event
- Event 64607
- Status
- Terminated
- Classification
- Class III
- Quantity
- 71,893 dispensers
- Official record key
drug-enforcement:D-246-2013
Official wording
Reason: Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Code information: Lot #: 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification