Recall: D-0527-2025
Class III - Minor Violations
Class IIIClassification
2025-06-11Initiated
OngoingStatus
Orient Pharma Co., Ltd. YunlinFirm
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
Failed Impurities/Degradation Specifications.
Distribution
NJ
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.