Class III
Ongoing
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.
This recall is currently active, issued July 9, 2025. It was issued by Orient Pharma Co., Ltd. Yunlin Plant.
- Recall Initiated
- June 11, 2025
- Posted
- July 9, 2025
- Recall Number
- D-0527-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20618 bottles
- Firm Location
- Yunlin County, Taiwan
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
NJ
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.
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