OurPharma LLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0385-2025Class IIIHYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLApril 15, 2025
D-0172-2023Class IIIFentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL CasseJanuary 13, 2023
D-0078-2023Class IIFentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml CasNovember 29, 2022