Multi-event March 2022 FDA Recall Drug by Fagron, Inc

This Multi-event Class III drug recall was voluntarily initiated by Fagron, Inc on March 4, 2022 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0864-2022 TERMINATED D-0863-2022 TERMINATED D-0866-2022 TERMINATED D-0865-2022 TERMINATED D-0862-2022 TERMINATED

Recall Number: D-0864-2022

Reason for Recall
Subpotent Drug
Initiated
03-04-2022
Reported
05-18-2022
Quantity
68 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 18H02-U02-044977, 18H02-U02-046140, 18L12-U02-050572, Exp. Date 10/31/2022; 18L12-U02-050308, 18L12-U02-000951, Exp. Date Sep 2023

Recall Number: D-0863-2022

Reason for Recall
Subpotent Drug
Initiated
03-04-2022
Reported
05-18-2022
Quantity
53 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 18H02-U02-044978, 18L12-U02-050018, Exp. Date 10/31/2022 18L12-U02-000952, Exp. Date Sep 2023

Recall Number: D-0866-2022

Reason for Recall
Subpotent Drug
Initiated
03-04-2022
Reported
05-18-2022
Quantity
1 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 18L12-U02-050019, Exp. Date 10/31/2022

Recall Number: D-0865-2022

Reason for Recall
Subpotent Drug
Initiated
03-04-2022
Reported
05-18-2022
Quantity
2 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 18L12-U02-050018, Exp. Date 10/31/2022

Recall Number: D-0862-2022

Reason for Recall
Subpotent Drug
Initiated
03-04-2022
Reported
05-18-2022
Quantity
58 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89797
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fagron, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-14-2024
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 18H02-U02-044979, 18H02-U02-046141, Exp. Date 10/31/2022; 18L12-U02-050309,18L12-U02-000953, 18L12-U02-A009829, Exp. Date Sep 2023.