Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial,
Summary
The FDA issued a Class I for Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous I by Par Sterile Products LLC. Reason: Presence of Particulate Matter..
Details
Source
Drug Recall
External ID
D-0429-2024
Action Date
2024-04-03
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot#: 57014; Exp, 04/30/2024
Quantity Affected: 466 vials
Reason for Recall
Presence of Particulate Matter.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-04
Company
Rochester, MI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 69 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Par Sterile Products LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Par Sterile Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Par Sterile Products LLC have FDA actions?
Par Sterile Products LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0429-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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