FDA recall D-1252-2020

Product

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

Reason for recall

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

Distribution

Nationwide with the United States and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2020-04-15

Report date

2020-04-29

Termination date

2021-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1252-2020