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Recall Observatory FDA recall evidence

Drug product

SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

D-0053-2023

October 07, 2022

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 90982
Status
Ongoing
Classification
Class II
Quantity
800.5 mL in unit dose vials
Official record key
drug-enforcement:D-0053-2023

Official wording

Reason: Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.

Code information: Lots: 65680, BUD: 10/11/2022; 66043, BUD: 10/15/2022; 66372, BUD: 10/23/2022; 66597, BUD: 10/29/2022

Distribution pattern: AL, LA, MS, and TN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility