FDA recall D-0559-2024

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03

Reason for recall

Failed Content Uniformity Specifications

Distribution

Nationwide in the US

Key facts

Status
Terminated
Initiation date
2024-05-30
Report date
2024-06-26
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-0559-2024