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Recall Enforment Report D-0693-2021

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Innoveix Pharmaceuticals Inc, originally initiated on 07-09-2021 for the product Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0693-202107-09-202107-28-2021Class II1,316 vialsCompounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910Lack of Assurance of SterilityCompleted
D-0692-202107-09-202107-28-2021Class II728 vialsCompounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910Lack of Assurance of SterilityCompleted