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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 466
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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