Treprostinil Injection recall
FDA recall D-0429-2024 · initiated Mar 4, 2024
Par Sterile Products LLC recalled Treprostinil Injection in Mar 2024 — an FDA Class I recall (D-0429-2024) because Presence of Particulate Matter.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 466 vials
Details
- 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
- Recalling company
- Par Sterile Products
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 4, 2024
- FDA report date
- Apr 3, 2024
Frequently asked
- Was Treprostinil Injection recalled?
- Par Sterile Products LLC recalled Treprostinil Injection in Mar 2024 — an FDA Class I recall (D-0429-2024) because Presence of Particulate Matter. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Treprostinil Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0429-2024 was: Presence of Particulate Matter.
- Is a recalled Treprostinil Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Treprostinil Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: 57014; Exp, 04/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0429-2024.