Recalls / Class I
Class ID-0429-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot#: 57014; Exp, 04/30/2024
Why it was recalled
Presence of Particulate Matter.
Recalling firm
- Firm
- Par Sterile Products LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, N/A, Rochester, Michigan 48307-1740
Distribution
- Quantity
- 466 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-03-04
- FDA classified
- 2024-03-28
- Posted by FDA
- 2024-04-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0429-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.