Par Sterile Products recalls
Par Sterile Products appears in 4 official U.S. recall notices indexed by RecallRadar, most recently on 2024-04-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 4 |
|---|---|
| Published | 2017-05-17 to 2024-04-03 |
| By agency | FDA Drug (4) |
| By classification | Class II (3), Class I (1) |
| By status | ongoing (2), terminated (2) |
| Distribution named in notices | US |
Recalls
- Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distribute…
FDA Drug · Class I · 2024-04-03 · Par Sterile Products
Reason: Presence of Particulate Matter. - Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready…
FDA Drug · Class II · 2024-01-24 · Par Sterile Products
Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. - Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 via…
FDA Drug · Class II · 2023-11-15 · Par Sterile Products
Reason: Crystallization; identified as Buprenorphine free base - Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42…
FDA Drug · Class II · 2017-05-17 · Par Sterile Products
Reason: 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.