FDA recall D-0375-2019

Product

Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA

Reason for recall

CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-01-02

Report date

2019-01-16

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0375-2019