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Recall Observatory FDA recall evidence

Drug 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

D-0941-2018

June 12, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 80307
Status
Terminated
Classification
Class II
Quantity
1,352 bags
Official record key
drug-enforcement:D-0941-2018

Official wording

Reason: Lack of Assurance of Sterility: Potential leakage of bags.

Code information: 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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility