D-0468-2023 Class II Terminated
FDA drug recall D-0468-2023 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on March 9, 2023 and is designated Class II. Reason for recall: Labeling: Label Mix-up The recall status is terminated (terminated December 4, 2023). Affected quantity: 69,375 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 29, 2023
- Initiation Date
- March 9, 2023
- Termination Date
- December 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,375 bottles
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
Reason for Recall
Labeling: Label Mix-up
Distribution Pattern
Product was distributed nationwide within the United States and PR
Code Information
Lot #: a) and b) E61835, exp. date JUN 2025