Drug recall D-0526-2025
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications.
Lots and codes
P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.
Recall details
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant, Yunlin County
- Quantity
- 57504 bottles
- Distribution
- NJ
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 11, 2025
Related products
- Pitavastatin – drug information
- NDC 0480-3633 Pitavastatin · Pitavastatin Calcium 4.18 mg/1 · Teva Pharmaceuticals, Inc.
- NDC 0480-3632 Pitavastatin · Pitavastatin Calcium 2.09 mg/1 · Teva Pharmaceuticals, Inc.
- NDC 0480-3631 Pitavastatin · Pitavastatin Calcium 1.045 mg/1 · Teva Pharmaceuticals, Inc.