Fagron recalls Nandrolone Decanoate USP for subpotency in multiple lots
Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate USP for prescription compounding due to subpotency. The affected lots were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class III voluntary pharmaceutical recall with no reported illnesses or adverse events. The hazard is subpotency, which affects therapeutic efficacy rather than acute safety.
Plain-English summary
Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate, USP, 100 g per plastic container, a prescription compounding pharmaceutical. The recall was initiated because the product was found to be subpotent—containing less active pharmaceutical ingredient than specified.
The affected product was distributed nationwide within the United States. The recalled lots are: 18H02-U02-044979 and 18H02-U02-046141 (expiring 10/31/2022), and 18L12-U02-050309, 18L12-U02-000953, and 18L12-U02-A009829 (expiring September 2023).
Healthcare providers and patients who have received this product should not use it and should contact their pharmacy or the recalling firm for guidance on replacement product.
The recalled product
- 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
- Manufacturer
- Fagron, Inc
- Category
- Drug — Prescription Compounding
- Hazard
- subpotent-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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.
Distribution
Distributed nationwide across the United States.
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