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Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu...

FDA Recall #D-0527-2025 — Class III — June 11, 2025

Recall #D-0527-2025 Date: June 11, 2025 Classification: Class III Status: Ongoing

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.

Recalling Firm

Orient Pharma Co., Ltd. Yunlin Plant — Yunlin County

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

20618 bottles

Distribution

NJ

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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