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Recall Observatory FDA recall evidence

Drug 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

D-0864-2022

March 04, 2022

Class III

Product summary

Firm
Fagron, Inc
Event
Event 89797
Status
Terminated
Classification
Class III
Quantity
68 containers
Official record key
drug-enforcement:D-0864-2022

Official wording

Reason: Subpotent Drug

Code 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

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent