Par Sterile Products LLC

FDA Regulatory Profile

Par Sterile Products LLC appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0429-2024, Class I) was initiated on March 4, 2024.

Summary

Total Recalls
4 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0429-2024Class ITreprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL March 4, 2024
D-0232-2024Class IIVasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x January 11, 2024
D-0087-2024Class IIBuprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single DoNovember 9, 2021
D-0698-2017Class IIBuprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL xApril 28, 2017