FDA recall D-0496-2024

Product

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

Reason for recall

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2024-04-24

Report date

2024-05-22

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-0496-2024