FDA recall D-0518-2024

Product

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

Reason for recall

Defective container: lack of seal integrity.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-05-08

Report date

2024-06-05

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-0518-2024