FDAHealthJune 11, 2025
Orient Pharma Co., Ltd. Yunlin Plant — 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:
⚠️ Failed Impurities/Degradation Specifications.
Is this relevant to me?
- Geography
- NJ
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2025
NJ
What's affected?
- 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.
- Brand
- PITAVASTATIN
- UPC
- 0304803633985
- Lot code
- 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.
Additional details
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.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 57504 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.