Multi event Drug Recall Enforcement Report Class III voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 05-16-2024 for the product Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8 The product was recalled due to failed impurities/degradation specifications.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0543-2024 | 05-16-2024 | 06-12-2024 | Class III | 13,440 units | Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8 | Failed Impurities/Degradation Specifications. | Ongoing |
| D-0542-2024 | 05-16-2024 | 06-12-2024 | Class III | 21,360 units | Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8 | Failed Impurities/Degradation Specifications. | Ongoing |
Recalled Products
