Recall archive / FDA company announcement

Par Pharmaceutical: Treprostinil 20mg/20mL Injection — FDA announcement Mar 12, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Mar 12, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Treprostinil 20mg/20mL Injection
Reason: Potential Presence of Silicone Particulate Matter
Classification: Not supplied
Recalling firm: Endo International, Par Pharmaceutical
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: c81f64eacc6b549e

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.; Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.; Vials from the affected lot bear this label: [see below]; Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.; Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.; Vials from the affected lot bear this label: [see below]; Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Mar 12, 2024
Company announcement date: Mar 12, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.