Recalls / Class II
Class IID-0729-2018
Product
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
- Affected lot / code info
- Lot #: 02122018@77, Exp 05/13/2018
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
- 2 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-0729-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.