Fagron, Inc

FDA Regulatory Profile

Summary

Total Recalls
22 (1 Class I)
510(k) Clearances
0
Inspections
11
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0155-2024Class IINYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription CDecember 11, 2023
D-0156-2024Class IINYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription ComDecember 11, 2023
D-0154-2024Class IINYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription CompDecember 11, 2023
D-0157-2024Class IINYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription CDecember 11, 2023
D-0862-2022Class IIINandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, FagroMarch 4, 2022
D-0856-2022Class ISyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b)March 4, 2022
D-0864-2022Class IIINandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, FagronMarch 4, 2022
D-0866-2022Class IIINandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, DistriMarch 4, 2022
D-0863-2022Class IIINandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, FagroMarch 4, 2022
D-0865-2022Class IIINandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, DistrMarch 4, 2022
D-0533-2020Class IILETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: LidocaiOctober 31, 2019
D-0547-2018Class IISyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, MaFebruary 14, 2018
D-0079-2018Class IIEstriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottleOctober 25, 2017
D-0695-2017Class IIIZinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, April 17, 2017
D-0792-2017Class IIEstrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottleApril 6, 2017
D-0791-2017Class IIEstriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle April 6, 2017
D-0655-2016Class IISyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vNovember 11, 2015
D-0654-2016Class IISyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to asNovember 11, 2015
D-0656-2016Class IISyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle speciallyNovember 11, 2015
D-1497-2014Class IIFagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-July 24, 2014