FDAHealthOctober 15, 2025
ProRx LLC — Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- TX, UT
- Source agency
- FDA
- Category
- Health
- Published
- October 15, 2025
TX and UT
What's affected?
- Product
- Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
- Brand
- ProRx LLC
- Lot code
- PRORX08062025-3
Additional details
Lot PRORX08062025-3
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,761 vials.
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