Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx o...
FDA Recall #D-0185-2024 — Class II — January 26, 2022
Product Description
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
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling Firm
CARDINAL HEALTHCARE — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1 unit
Distribution
Nationwide USA
Code Information
Batch D41919
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated