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Par Sterile Products LLC FDA Recalls

3 recalls on file across drugs, 1 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Class IMar 4, 2024Presence 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 VialsClass IIJan 11, 2024Superpotent Drug: Assay from the 3-month and 6-month stabili
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied iClass IINov 9, 2021Crystallization; identified as Buprenorphine free base

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