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.
Reported: July 9, 2025 Initiated: June 11, 2025 #D-0527-2025
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.
Details
- Recalling Firm
- Orient Pharma Co., Ltd. Yunlin Plant
- Units Affected
- 20618 bottles
- Distribution
- NJ
- Location
- Yunlin County
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Orient Pharma Co., Ltd. Yunlin Plant. Units affected: 20618 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 9, 2025. Severity: Low. Recall number: D-0527-2025.
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