TIRZEPATIDE 60 mg/ recalled over sterility concerns
- Recall date
- August 22, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ProRx LLC recalls TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
- Recall number
- D-0656-2024
- FDA classification
- Class II
- Brand / firm
- ProRx LLC
- Sold / distributed
- Nationwide in the USA
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
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
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