FDA-Drug2020-04-29Class II

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Lupin Pharmaceuticals Inc.
Hazard

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Sold states
Nationwide with the United States and Puerto Rico.
Affected count
4,518 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, 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-1252-2020

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