FDA-Drug2024-09-04Class II
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
Lupin Pharmaceuticals Inc.
Hazard
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Sold states
USA nationwide.
Affected count
4554 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2024Don't want to check this manually?
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