Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Ba…
- Recall date
- August 21, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0648-2024
- FDA classification
- Class II
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- USA nationwide.
Why it was recalled
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
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