Vitalab Pharmacy, Inc recalls Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Pros
Recalled May 16, 2018 · FDA recall D-0732-2018 · 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
N/A
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 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
Manufacturer(s)
Vitalab Pharmacy, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →