Drug 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.
D-0527-2025
Product summary
- Event
- Event 97076
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 20618 bottles
- Official record key
drug-enforcement:D-0527-2025
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: 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.
Distribution pattern: NJ
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications