FDA recall D-0306-2020

Product

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

Reason for recall

Presence of Foreign substance: identified as a dead ant.

Distribution

Product was distributed to major distributors/wholesalers throughout the United States.

Key facts

Status

Terminated

Initiation date

2019-11-01

Report date

2019-11-13

Termination date

2021-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0306-2020