Recalls / Class II
Class IID-0733-2018
Product
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
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Vitalab Pharmacy, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4045 E Bell Rd Ste 163, N/A, Phoenix, Arizona 85032-2240
Distribution
- Quantity
- 60 vials
- Distribution pattern
- The recalled product was distributed to patients throughout the United States.
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-09
- Posted by FDA
- 2018-05-16
- Terminated
- 2020-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0733-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.