Recalls / Class II

Class IID-0656-2024

Product

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

Affected lot / code info

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

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

ProRx LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

619 Jeffers Cir, Exton, Pennsylvania 19341-2540

Distribution

Quantity

1,732 vials

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-08-22

FDA classified

2024-09-05

Posted by FDA

2024-09-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0656-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.