FDA recall D-0733-2018

Product

Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc

Reason for recall

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

Distribution

The recalled product was distributed to patients throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-04-24

Report date

2018-05-16

Termination date

2020-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0733-2018