FDA-Drug2024-09-11Class II

Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01

ProRx LLC
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
37 vials
Manufactured in
619 Jeffers Cir, Exton, PA, United States
Products
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2024

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