Drug & medication recalls Moderate risk

Innoveix Pharmaceuticals product recalled over sterility concerns

Recall date
July 9, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Innoveix Pharmaceuticals Inc recalls Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: I…
Recall number
D-0692-2021
FDA classification
Class II
Brand / firm
Innoveix Pharmaceuticals Inc
Sold / distributed
Nationwide within the United States

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

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