Vitalab Pharmacy, Inc recalls Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Recalled May 16, 2018 · FDA recall D-0730-2018 · 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
22 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 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc
Manufacturer(s)
Vitalab Pharmacy, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →