Home / Recalls / Fagron, Inc / D-0154-2024

D-0154-2024 Class II Ongoing

Recalled by Fagron, Inc — Saint Paul, MN

Recall Details

Product Type
Drugs
Report Date
December 27, 2023
Initiation Date
December 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 containers

Product Description

NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3

Reason for Recall

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Distribution Pattern

Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.

Code Information

Lot#: 230308-U46196, Exp. date 04/30/2025

Other recalls by Fagron, Inc

  • D-0155-2024 Class II — NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only (December 11, 2023)
  • D-0156-2024 Class II — NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, (December 11, 2023)
  • D-0157-2024 Class II — NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only (December 11, 2023)
  • D-0856-2022 Class I — SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC (March 4, 2022)
  • D-0865-2022 Class III — Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescriptio (March 4, 2022)
  • D-0866-2022 Class III — Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription (March 4, 2022)
  • D-0863-2022 Class III — Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescriptio (March 4, 2022)
  • D-0864-2022 Class III — Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription (March 4, 2022)
  • D-0862-2022 Class III — Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescriptio (March 4, 2022)
  • D-0533-2020 Class II — LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powde (October 31, 2019)