FDA Drug Recalls

Recalls / Class III

Class IIID-0865-2022

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

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

Why it was recalled

Subpotent Drug

Recalling firm

Firm
Fagron, Inc
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
2400 Pilot Knob Rd, N/A, Saint Paul, Minnesota 55120-1118

Distribution

Quantity
2 containers
Distribution pattern
Nationwide within the USA

Timeline

Recall initiated
2022-03-04
FDA classified
2022-05-11
Posted by FDA
2022-05-18
Terminated
2024-07-14
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0865-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls