Drug 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
D-0429-2024
Product summary
- Event
- Event 94166
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 466 vials
- Official record key
drug-enforcement:D-0429-2024
Official wording
Reason: Presence of Particulate Matter.
Code information: Lot#: 57014; Exp, 04/30/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter