Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01

FDA recall notice · announced April 3, 2024 · Par Sterile Products

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01

Reason for recall

Presence of Particulate Matter.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot#: 57014; Exp, 04/30/2024
Quantity: 466 vials
Status: Ongoing
Products in this recall event:
- Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 4202 (D-0429-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.