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Recall Observatory FDA recall evidence

Drug product

LAURETH-9 INJ 2% Solution, 30 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

D-0034-2023

October 07, 2022

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 90982
Status
Ongoing
Classification
Class II
Quantity
3 vials
Official record key
drug-enforcement:D-0034-2023

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: Lot: 66513, BUD: 11/10/2022

Distribution pattern: AL, LA, MS, and TN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility