Drug recall D-0527-2025
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.
Reason for recall
Failed Impurities/Degradation Specifications.
Lots and codes
P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
Recall details
- Recalling firm
- Orient Pharma Co., Ltd. Yunlin Plant, Yunlin County
- Quantity
- 20618 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.