Drug recall D-0468-2023

Class II Terminated reported Mar 29, 2023

Product

JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA

Reason for recall

Labeling: Label Mix-up

Lots and codes

Lot #: a) and b) E61835, exp. date JUN 2025

Recall details

Recalling firm
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Quantity
69,375 bottles
Distribution
Product was distributed nationwide within the United States and PR
Type
Voluntary: Firm initiated
Recall initiated
March 9, 2023
Terminated
December 4, 2023

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