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Home › Prescription medicine › Par Sterile Products LLC — Treprostinil…

Food & drug recall · FDAMarch 4, 2024Highest risk

Par Sterile Products LLC — Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Presence of Particulate Matter.

The Recall Registry rates this highest risk — FDA Class I: reasonable probability of serious harm or death.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Par Sterile Products LLC

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

Details

Units affected
466 vials
Recall date
March 4, 2024
Brand
Par Sterile Products LLC
Model, lot or SKU numbers
Lot#: 57014Exp, 04/30/2024
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Par Sterile Products LLC — 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”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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