← FDA ENFORCEMENT
D-0656-2024Class 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
1,732 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02

Code / lot info

Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024

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.