Recalls / Class II
Class IID-0655-2024
Product
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
- Affected lot / code info
- Lot # ProRx051424, BUD 11/13/2024
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
- 1,489 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-0655-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.