CLASS I ONGOING Drug recall · Reported 3 Apr 2024 · FDA Enforcement Report
Treprostinil Injection, 20 mg/ (1 mg/mL) recalled
Par Sterile Products is recalling Treprostinil Injection, 20 mg/ (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, distributed nationwide in the US. The recall was initiated on 4 Mar 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0429-2024
- FDA event ID
- 94166
- Recalling firm
- Par Sterile Products, Rochester, MI
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 4 Mar 2024
- FDA classified
- 28 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Mar 2024 | Recall initiated by company | |
| 28 Mar 2024 | Classified by FDA | +24 days |
| 3 Apr 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter.
Which lots are affected?
Lot#: 57014; Exp, 04/30/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Par Sterile Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vasostrict (vasopressin in 5% Dextrose) Injection per mL) recalledVasostrict | Par Sterile Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Buprenorphine HCl, Injection, 0.3mg/mL recalled by PAR Sterile ProductsBuprenorphine Hydrochloride | PAR Sterile Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Buprenorphine HCI Injection, 0.3 mg/mL Single Dose Vial recalledBuprenorphine Hydrochloride | PAR Sterile Products | Particulate Matter | Nationwide |
Other Treprostinil recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tyvaso Inhalation System Patient a) Starter Kit with Tyvaso recalledTyvaso | United Therapeutics | Other | IL, PA |