FDA-Drug2018-05-16Class II
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
Vitalab Pharmacy, Inc
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.
Sold states
The recalled product was distributed to patients throughout the United States.
Affected count
N/A
Manufactured in
4045 E Bell Rd Ste 163, N/A, Phoenix, AZ, United States
Products
Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2018Don't want to check this manually?
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