Ketoconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Ketoconazole USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
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 hazard is a lack of stability data, which is a quality control issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling specific lots of Ketoconazole USP for prescription compounding. The affected product is packaged in 25g, 100g, and 500g containers and is available by prescription only. The recall covers approximately 4,600 grams of product 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. This deficiency means the product's stability over time has not been adequately verified.
Healthcare professionals and pharmacies should stop using the affected lots immediately. Patients who have already used the product should contact their healthcare provider for guidance. The affected lot numbers are 091115-1 and 091115-2, all with an expiration date of 07/31/2020.
The recalled product
- Product
- Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) 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
- 4,600
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 (6)
- Lot #: a) 091115-1
- Exp. 07/31/2020
- 091115-2
- b) 091115-1
- c) 091115-1
- Exp. 07/31/2020.
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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