Fagron Recalls
22 recalls on record · August 6, 2014 to December 27, 2023 · Drugs
Recalls by year
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16
17
18
19
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, I
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, In
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 740
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 74
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Kn
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot K
Hazard: Subpotent Drug
May 18, 2022DrugsFDA
Fagron, Inc recalls SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 515
Hazard: Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
December 11, 2019DrugsFDA
Fagron, Inc recalls LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4
Hazard: Microbial contamination of non-sterile product.
March 7, 2018DrugsFDA
Fagron, Inc recalls SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron
Hazard: Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
November 22, 2017DrugsFDA
Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2)
Hazard: cGMP Deviations: lack of quality assurance at the API manufacturer.
May 31, 2017DrugsFDA
Fagron, Inc recalls Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2),
Hazard: cGMP Deviations: lack of quality assurance at the API manufacturer.
May 31, 2017DrugsFDA
Fagron, Inc recalls Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2),
Hazard: cGMP Deviations: lack of quality assurance at the API manufacturer.
May 10, 2017DrugsFDA
Fagron, Inc recalls Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522
Hazard: Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
February 17, 2016DrugsFDA
Fagron, Inc recalls SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assis
Hazard: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
February 17, 2016DrugsFDA
Fagron, Inc recalls SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially for
Hazard: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
February 17, 2016DrugsFDA
Fagron, Inc recalls SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneo
Hazard: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
August 6, 2014DrugsFDA
Fagron, Inc recalls Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsi
Hazard: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
August 6, 2014DrugsFDA
Fagron, Inc recalls Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, P
Hazard: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
August 6, 2014DrugsFDA
Fagron, Inc recalls Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying
Hazard: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.