FDA-Drug2025-07-09Class III
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.
Orient Pharma Co., Ltd. Yunlin Plant
Hazard
Failed Impurities/Degradation Specifications.
Sold states
NJ
Affected count
20618 bottles
Manufactured in
No. 8 Kehu 1st Rd., Huwei Township, Yunlin County, Taiwan
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2025Don't want to check this manually?
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