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Recall Observatory FDA recall evidence

Drug product

Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.

D-0662-2022

August 06, 2020

Class II

Product summary

Firm
Family Pharmacy of Statesville
Event
Event 89773
Status
Terminated
Classification
Class II
Quantity
3 bottles
Official record key
drug-enforcement:D-0662-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 07312020@2 BUD: 9/14/2020

Distribution pattern: NC only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility