JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) b
Summary
The FDA issued a Class II for JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153- by Boehringer Ingelheim Pharmaceuticals, Inc.. Reason: Labeling: Label Mix-up.
Details
Source
Drug Recall
External ID
D-0468-2023
Action Date
2023-03-29
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: a) and b) E61835, exp. date JUN 2025
Quantity Affected: 69,375 bottles
Reason for Recall
Labeling: Label Mix-up
Distribution
Product was distributed nationwide within the United States and PR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-09
Company
Ridgefield, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boehringer Ingelheim Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boehringer Ingelheim Pharmaceuticals, Inc. have FDA actions?
This is the only FDA action we have on record for Boehringer Ingelheim Pharmaceuticals, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0468-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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