Drug Enforcement D-0468-2023

Labeling: Label Mix-up

Status

Terminated

Classification

Class II

Report Date

March 29, 2023

Termination Date

December 4, 2023

Product Information

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
Product quantity
69,375 bottles
Reason for recall
Labeling: Label Mix-up
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Product was distributed nationwide within the United States and PR

Location & Firm

Recalling firm
Boehringer Ingelheim Pharmaceuticals, Inc.
Address
900 Ridgebury Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0468-2023
Event ID
91879
Recall initiation date
March 9, 2023
Center classification date
March 17, 2023
Code info
Lot #: a) and b) E61835, exp. date JUN 2025
More code info
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