D-0429-2024 Class I Ongoing
FDA drug recall D-0429-2024 was initiated by Par Sterile Products LLC on March 4, 2024 and is designated Class I. Reason for recall: Presence of Particulate Matter. The recall status is ongoing. Affected quantity: 466 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 3, 2024
- Initiation Date
- March 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 466 vials
Product Description
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
Reason for Recall
Presence of Particulate Matter.
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: 57014; Exp, 04/30/2024