Saint Paul, MN, United States
Fagron, Inc recalls
5 recalls recorded since 2018, most recently on 11 December 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)1
Terminated or completed4
Class I (FDA)1
Ongoing Class II Drugs
- Recall started
- 11 December 2023
- Reason
- Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0154-2024, D-0155-2024, D-0156-2024, D-0157-2024
- 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
- NYSTATIN 500 MU, 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 51552-0041-3, Bar code 3 51552 00413 9
- NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
- NYSTATIN 150 MU, 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 51552-0041-1, Bar code 3 51552 00411 5
Terminated Class III Drugs
- Recall started
- 4 March 2022
- Terminated
- 14 July 2024
- Reason
- Subpotent Drug
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0864-2022, D-0865-2022, D-0862-2022, D-0863-2022, D-0866-2022
- Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
- Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
- Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
- Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
- Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
Completed Class I Drugs
- Recall started
- 4 March 2022
- Reason
- Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
- Distribution
- Nationwide USA and Puerto Rico, Canada, Columbia, France
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0856-2022
- SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
Terminated Class II Drugs
- Recall started
- 31 October 2019
- Terminated
- 6 November 2020
- Reason
- Microbial contamination of non-sterile product.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0533-2020
- LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 m
Terminated Class II Drugs
- Recall started
- 14 February 2018
- Terminated
- 10 September 2019
- Reason
- Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
- Distribution
- Nationwide, USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0547-2018
- SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.