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FDARecalled Sep 4, 2024 · #D-0648-2024

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 IND...

Hazard

Class II — temporary health risk

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Description

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. Classification: Class II Distribution: USA nationwide.

Product details

Product
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
Type
Drugs
Manufacturer
Lupin Pharmaceuticals Inc.
Model numbers
F201517
UPCs