D-0733-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- January 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 vials
Product Description
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
Reason for Recall
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.
Distribution Pattern
The recalled product was distributed to patients throughout the United States.
Code Information
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