Vitalab Pharmacy, Inc recalls Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papa
Recalled May 16, 2018 · FDA recall D-0733-2018 · Vitalab Pharmacy
Hazard
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. · FDA Class II
Units
60 vials
Sold at
The recalled product was distributed to patients throughout the United States.
Description
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.
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
Manufacturer(s)
Vitalab Pharmacy, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →