Brand
Par Sterile Products LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Par Sterile Products LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-04-03FDA-DrugClass ITreprostinil 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
Presence of Particulate Matter.
- 2024-01-24FDA-DrugClass IIVasostrict (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 to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
- 2023-11-15FDA-DrugClass IIBuprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.
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