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Class III: unlikely to cause harmTerminated

Fagron Nandrolone Decanoate Recall

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compo…

Fagron, Inc · Saint Paul, MN

Risk level
Class III
Reported by FDA
May 18, 2022
Recall ID
D-0865-2022
Check your lot numberHow we source this data

Summary

Fagron recalled Nandrolone Decanoate starting Mar 4, 2022. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0865-2022 on May 18, 2022. Reason: Subpotent Drug. Status: Terminated.

Why it was recalled

Subpotent Drug

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0865-2022
Classification
Class III
Status
Terminated
Recall initiated
Mar 4, 2022
FDA report date
May 18, 2022
Quantity
2 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Fagron, Inc

Original FDA data

Every field from FDA enforcement report D-0865-2022, exactly as published.

Show all FDA fields
City
Saint Paul
State
MN
Status
Terminated
Country
United States
Event ID
89797
Address
2400 Pilot Knob Rd
Code information
Lot #: 18L12-U02-050018, Exp. Date 10/31/2022
Postal code
55120-1118
Report date
May 18, 2022
Product type
Drugs
Recall number
D-0865-2022
Classification
Class III
Recalling firm
Fagron, Inc
Product quantity
2 containers
Termination date
Jul 14, 2024
Reason for recall
Subpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide within the USA
Recall initiation date
Mar 4, 2022
Initial firm notification
Letter
Center classification date
May 11, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0865-2022, published May 18, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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