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Recall Observatory FDA recall evidence

Drug product

Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

D-0528-2016

November 10, 2015

Class II

Product summary

Firm
Walgreens Infusion Services
Event
Event 72594
Status
Terminated
Classification
Class II
Quantity
95 Accuflo bags
Official record key
drug-enforcement:D-0528-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry.

Distribution pattern: Texas

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility