FDA recall D-0352-2019

Product

Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31

Reason for recall

Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-01-02

Report date

2019-01-16

Termination date

2021-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2019