Nandrolone Decanoate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.
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: The recall is classified as FDA Class II, which corresponds to a moderate severity score of 2 under the rubric for minor labeling or documentation issues where the risk is theoretical and no illnesses are reported.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The total quantity involved is 86,225 g.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that may have received the affected lots. Consumers should not use the product and should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 86,225
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 (15)
- Lot #: a) 012716-1
- 012716-2
- Exp. 01/12/2019
- 110316-3
- Exp. 09/21/2021 b) 012716-1
- 012716-3
- 110316-1
- Exp. 09/21/2021
- c) 012716-1
- 110316-2
- exp. 09/21/2021
- d) 012716-1
- 041717-2
- Exp. 04/06/2022
- Exp. 09/21/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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