Oxandrolone USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support 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 typically indicates a situation where use of the product might cause temporary or medically reversible health consequences. The specific hazard is a lack of stability data, which is a quality control issue rather than a confirmed contamination or acute safety defect.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Oxandrolone USP for prescription compounding, packaged in 25g, 100g, and 500g containers. The product is prescription-only and was distributed nationwide within the United States.
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.
Affected lots include 012616-2 and 012616-1 for the 25g and 100g packages, and 012616-1 and 012616-3 for the 500g packages, all with an expiration date of 01/08/2019. Consumers and healthcare providers should stop using the product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), 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
- 24,025
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 #: a) 012616-2
- Exp. 01/08/2019
- b) 012616-1
- 012616-2
- c) 012616-1
- 012616-3
- Exp. 01/08/2019.
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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