Drug 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.
D-0526-2025
Product summary
- Event
- Event 97076
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 57504 bottles
- Official record key
drug-enforcement:D-0526-2025
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: 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.
Distribution pattern: NJ
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications