Recall D-0527-2025

US Class III Ongoing · initiated 2025-06-11

Recalling firm

Orient Pharma Co., Ltd. Yunlin Plant

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.

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