Multi event Drug Recall Enforcement Report Class III voluntary initiated by Teva Pharmaceuticals USA, Inc., originally initiated on 03-12-2013 for the 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. The product was recalled due to failed tablet/capsule specifications: this recall is being carried out due to an out of specification result for appearance.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-246-2013 | 03-12-2013 | 04-17-2013 | Class III | 71,893 dispensers | 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. | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. | Terminated |
| D-245-2013 | 03-12-2013 | 04-17-2013 | Class III | 17,661 blister cards | Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58. | Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance. | Terminated |
Recalled Products
