Boehringer Ingelheim Pharmaceuticals, Inc.: Drug Recall

Recall #D-0468-2023 · 03/09/2023

Class II: Risk

Recall Details

Recall Number
D-0468-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Status
Terminated
Date Initiated
03/09/2023
Location
Ridgefield, CT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
69,375 bottles

Reason for Recall

Labeling: Label Mix-up

Product Description

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

Distribution Pattern

Product was distributed nationwide within the United States and PR

Other Recalls by Boehringer Ingelheim Pharmaceuticals, Inc.

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.