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Recall Observatory FDA recall evidence

Drug product

Pitavastatin Tablets, 2 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 0480-3632-98.

D-0526-2025

June 11, 2025

Class III

Product summary

Firm
Orient Pharma Co., Ltd. Yunlin Plant
Event
Event 97076
Status
Ongoing
Classification
Class III
Quantity
57504 bottles
Official record key
drug-enforcement:D-0526-2025

Official wording

Reason: Failed Impurities/Degradation Specifications.

Code information: P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.

Distribution pattern: NJ

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications