Home / Recalls / ProRx LLC / D-0655-2024

D-0655-2024 Class II Ongoing

Recalled by ProRx LLC — Exton, PA

Recall Details

Product Type
Drugs
Report Date
September 11, 2024
Initiation Date
August 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,489 vials

Product Description

TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot # ProRx051424, BUD 11/13/2024

Other recalls by ProRx LLC

  • D-0117-2026 Class II — Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutan (October 15, 2025)
  • D-0118-2026 Class II — Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneo (October 15, 2025)
  • D-0116-2026 Class II — Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutan (October 15, 2025)
  • D-0119-2026 Class II — Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneo (October 15, 2025)
  • D-0114-2026 Class II — Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneou (October 15, 2025)
  • D-0115-2026 Class II — Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutane (October 15, 2025)
  • D-0120-2026 Class II — Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneou (October 15, 2025)
  • D-0651-2024 Class II — Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Comp (August 22, 2024)
  • D-0650-2024 Class II — Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass via (August 22, 2024)
  • D-0654-2024 Class II — Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, (August 22, 2024)