FDAFDA · Food and drugs·Recall number D-0733-2018
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
Published May 16, 2018 · Recall initiated: April 24, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vitalab Pharmacy, Inc
- Distributor
- The recalled product was distributed to patients throughout the United States.
- Lot
- Lot #:T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, T106 03122018@64, 02072018@97, Exp 06/04/2018-06/10/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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