Recalls / Class III
Class IIID-0864-2022
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
- Affected lot / code info
- 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
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
- 68 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-0864-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.