FDAClass IIJanuary 3, 2024

Jardiance recall: CGMP Deviations

Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37

Why was Jardiance recalled?

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch D41919

Product
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
Recalling firm
CARDINAL HEALTHCARE
Quantity
1 unit
Distribution
Nationwide USA
Recall date
January 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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