Multi event Drug Recall Enforcement Report Class III voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 06-17-2014 for the product Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 The product was recalled due to failed impurities/degradation specifications: out of specification impurity test results.. 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-1436-2014 | 06-17-2014 | 07-23-2014 | Class III | 1104 blister packs | Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Terminated |
| D-1437-2014 | 06-17-2014 | 07-23-2014 | Class III | 984 blister packs | Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Terminated |
| D-1439-2014 | 06-17-2014 | 07-23-2014 | Class III | 5265 blister packs | Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Terminated |
| D-1438-2014 | 06-17-2014 | 07-23-2014 | Class III | 1125 blister packs | Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58 | Failed Impurities/Degradation Specifications: out of specification impurity test results. | Terminated |
Recalled Products
