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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 57014; Exp, 04/30/2024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Par Sterile Products LLC
- Reason for Recall:
- Presence of Particulate Matter.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
Lot#: 57014; Exp, 04/30/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0429-2024
Related Recalls
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.