Pitavastatin tablets recalled for failed impurities and degradation specifications

Plain-English summary

Teva Pharmaceuticals is recalling Pitavastatin (Pitavastatin Calcium) 2 mg tablets, 90-tablet bottles (NDC 0480-3632-98 and related package codes), manufactured by Orient Pharma Co., Ltd. Yunlin Plant in Taiwan. The recall affects 57,504 bottles distributed in New Jersey. Specific lot numbers affected are P061001, P061002, P061003, P061004, P061006, P061007, P061008, P061009, P061010, P061011, P061012, P061013, P061016, P061017, P061018, P061019, and P061023, with expiration dates ranging from July 2025 through January 2027.

The recall was initiated due to failed impurities and degradation specifications. This is a Class III recall, indicating that the product is unlikely to cause adverse health consequences.

Consumers who have dispensed or received these affected lots should contact their pharmacy or healthcare provider. Do not use recalled product; return it to the pharmacy or contact Teva Pharmaceuticals for return instructions.

The recalled product

Product

PITAVASTATIN (PITAVASTATIN CALCIUM)

Brand

PITAVASTATIN

Manufacturer

Orient Pharma Co., Ltd. Yunlin Plant

Category

Drug — Statin / Cardiovascular

Hazard

• impurity
• degradation-product

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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