Boehringer Ingelheim Pharmaceuticals, Inc. recalls JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90)…
- Recall date
- March 9, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0468-2023
- FDA classification
- Class II
- Brand / firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Sold / distributed
- Product was distributed nationwide within the United States and PR
Why it was recalled
Labeling: Label Mix-up
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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