Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc
Reported: May 16, 2018 Initiated: April 24, 2018 #D-0729-2018
Product Description
Alprostadil 20 mcg/mL, Sterile injectable, 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.
Details
- Recalling Firm
- Vitalab Pharmacy, Inc
- Units Affected
- 2 vials
- Distribution
- The recalled product was distributed to patients throughout the United States.
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc. Recalled by Vitalab Pharmacy, Inc. Units affected: 2 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 16, 2018. Severity: Moderate. Recall number: D-0729-2018.
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