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Recall Observatory FDA recall evidence

Drug product

ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

D-0027-2023

October 07, 2022

Class II

Product summary

Firm
Pharmacy Plus, Inc. dba Vital Care Compounder
Event
Event 90982
Status
Ongoing
Classification
Class II
Quantity
2 droptainers
Official record key
drug-enforcement:D-0027-2023

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: 66017, BUD: 10/13/2022; 66177, BUD: 10/19/2022

Distribution pattern: AL, LA, MS, and TN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility