FDA recall D-0648-2024

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

Reason for recall

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2024-08-21

Report date

2024-09-04

Termination date

2025-04-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0648-2024