Multi event Drug Recall Enforcement Report Class III voluntary initiated by Orient Pharma Co., Ltd. Yunlin Plant, originally initiated on 06-11-2025 for the product Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98. The product was recalled due to failed impurities/degradation specifications.. The product was distributed in Nj 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-0527-2025 | 06-11-2025 | 07-09-2025 | Class III | 20618 bottles | Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98. | Failed Impurities/Degradation Specifications. | Ongoing |
| D-0526-2025 | 06-11-2025 | 07-09-2025 | Class III | 57504 bottles | Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98. | Failed Impurities/Degradation Specifications. | Ongoing |
Recalled Products
