FDA Recall D-0429-2024

Par Sterile Products LLC · Rochester, MI

Class I — life-threatening Ongoing 801 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

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

Lot / code: Lot#: 57014; Exp, 04/30/2024

Quantity: 466 vials

Reason for recall

Presence of Particulate Matter.

Recall record

Recall number: D-0429-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-03-04
Classified by FDA Center: 2024-03-28
FDA published: 2024-04-03
Recalling firm: Par Sterile Products LLC
Firm location: Rochester, MI

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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