Treprostinil Injection recalled nationwide due to particulate matter contamination
Par Pharmaceutical is recalling Treprostinil Injection nationwide due to the presence of particulate matter. This FDA Class I recall affects 466 vials of lot 57014 distributed throughout the United States.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which designates a reasonable probability of serious adverse health consequences or death. Per the recall rubric, FDA Class I recalls receive a minimum severity score of 4. No specific illnesses or injuries have been reported in the source material.
Plain-English summary
Par Sterile Products LLC is recalling Treprostinil Injection, 20 mg/20 mL (1 mg/mL), in 20 mL multiple-dose vials. The affected lot is lot number 57014, with expiration date 04/30/2024. Approximately 466 vials were distributed nationwide throughout the United States.
The Food and Drug Administration (FDA) has classified this as a Class I recall due to the presence of particulate matter in the product.
Patients and healthcare providers who have received this product should be aware of the recall. Anyone possessing vials from lot 57014 with an expiration date of 04/30/2024 should consult with their healthcare provider regarding this recall.
The recalled product
- 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
- Manufacturer
- Par Sterile Products LLC
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- particulate-matter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: 57014
- Exp
- 04/30/2024
Distribution
Distributed nationwide across the United States.
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