Recalls / Class II
Class IID-0941-2018
Product
Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
- Affected lot / code info
- Lot # 138-20181005@92, 138-20181005@91, 138-20181005@90, BUD 7/9/2018; 138-20181405@78, BUD 7/13/2018; 138-20181605@61, BUD 7/15/2018
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
- 1,352 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-0941-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.