Drug Enforcement D-0526-2025

Failed Impurities/Degradation Specifications.

Status

Ongoing

Classification

Class III

Report Date

July 9, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
57504 bottles
Reason for recall
Failed Impurities/Degradation Specifications.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
NJ

Location & Firm

Recalling firm
Orient Pharma Co., Ltd. Yunlin Plant
Address
No. 8 Kehu 1st Rd., Huwei Township

Taiwan
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0526-2025
Event ID
97076
Recall initiation date
June 11, 2025
Center classification date
July 16, 2025
Code info
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.
More code info
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