Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen,
Summary
The FDA issued a Class III for Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma by Orient Pharma Co., Ltd. Yunlin Plant. Reason: Failed Impurities/Degradation Specifications..
Details
Source
Drug Recall
External ID
D-0527-2025
Action Date
2025-07-09
Status
Ongoing
Category
drug
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.
Lot/Code Info: 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.
Quantity Affected: 20618 bottles
Reason for Recall
Failed Impurities/Degradation Specifications.
Distribution
NJ
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-11
Company
Yunlin County
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Orient Pharma Co., Ltd. Yunlin Plant has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Orient Pharma Co., Ltd. Yunlin Plant) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Orient Pharma Co., Ltd. Yunlin Plant have FDA actions?
Orient Pharma Co., Ltd. Yunlin Plant has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0527-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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