Recalls / Class III
Class IIID-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.
- 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
- 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.
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
- 20618 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-0527-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.