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Recall Observatory FDA recall evidence

Drug product

Vancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.

D-1188-2015

May 28, 2015

Class II

Product summary

Firm
Lincare, Inc.
Event
Event 71415
Status
Terminated
Classification
Class II
Quantity
7 Bags
Official record key
drug-enforcement:D-1188-2015

Official wording

Reason: Lack of Assurance of Sterility: Sterility of product is not assured.

Code information: Compounded on 05/28/15, Discard After: 06/11/15

Distribution pattern: United States including: Arkansas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility