FDA recall D-0094-2019

Product

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-10-15

Report date

2018-10-31

Termination date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2019