Recalls / Class III
Class IIID-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.
- Brand name
- Pitavastatin
- Generic name
- Pitavastatin Calcium
- Active ingredient
- Pitavastatin Calcium
- Route
- Oral
- NDCs
- 0480-3631, 0480-3632, 0480-3633
- FDA application
- ANDA205932
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- Orient Pharma Co., Ltd. Yunlin Plant
- Manufacturer
- Teva Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- No. 8 Kehu 1st Rd., Huwei Township, Yunlin County, N/A, Taiwan
Distribution
- Quantity
- 57504 bottles
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2025-06-11
- FDA classified
- 2025-07-16
- Posted by FDA
- 2025-07-09
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0526-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.