FDA recall D-0527-2025

Orient Pharma Co., Ltd. Yunlin Plant · Class III · drug

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.

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution

NJ

Key facts

Status
Ongoing
Initiation date
2025-06-11
Report date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yunlin County, Taiwan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2025