← FDA ENFORCEMENT
D-0651-2024Class II

ProRx LLC

Recalling firm
ProRx LLC
Product type
Drug
Status
Ongoing
Report date
2024-09-11
Distribution
Nationwide in the USA
Firm state
PA
Product quantity
37 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

Lot # ProRx040924-1, BUD 10/08/2024

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IArgon Medical Devices, Inc2026-07-22Class IIOlympus Corporation of the Americas2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.