Recalls / Class II
Class IID-0962-2018
Product
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
- Affected lot / code info
- Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. .
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 120 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-12
- FDA classified
- 2018-07-19
- Posted by FDA
- 2018-07-25
- Terminated
- 2020-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0962-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.