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
Reported: April 3, 2024 Initiated: March 4, 2024 #D-0429-2024
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.
Details
- Recalling Firm
- Par Sterile Products LLC
- Units Affected
- 466 vials
- Distribution
- Nationwide in the USA
- Location
- Rochester, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Par Sterile Products LLC. Units affected: 466 vials.
Why was this product recalled? ▼
Presence of Particulate Matter.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2024. Severity: Critical. Recall number: D-0429-2024.
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