Home / Recalls / Orient Pharma Co., Ltd. Yunlin Plant / D-0527-2025

D-0527-2025 Class III Ongoing

Recalled by Orient Pharma Co., Ltd. Yunlin Plant — Yunlin County

Recall Details

Product Type
Drugs
Report Date
July 9, 2025
Initiation Date
June 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20618 bottles

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications.

Distribution Pattern

NJ

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.

Other recalls by Orient Pharma Co., Ltd. Yunlin Plant

  • D-0526-2025 Class III — Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma (June 11, 2025)