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Recall Observatory FDA recall evidence

Drug 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.

D-0527-2025

June 11, 2025

Class III

Product summary

Firm
Orient Pharma Co., Ltd. Yunlin Plant
Event
Event 97076
Status
Ongoing
Classification
Class III
Quantity
20618 bottles
Official record key
drug-enforcement:D-0527-2025

Official wording

Reason: Failed Impurities/Degradation Specifications.

Code information: P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, 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