American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.
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 CGMP deviation regarding stability data, which is a quality control issue rather than a direct contamination or acute injury risk, fitting the 'Moderate' criteria for minor labeling or quality errors without reported illness.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only. The product is identified by NDC 58597-8634-2 and Lot # 071015-1, with an expiration date of 3/7/2018. The recall is distributed nationwide within the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm lacked stability data and controls necessary to support the assigned retest or expiration date for the product in its container/closure system.
This recall affects pharmacies and compounding facilities that may have purchased this specific lot of Desoximetasone USP. Consumers who have been prescribed this medication should consult their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
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 (2)
- Lot #: 071015-1
- Exp. 3/7/2018
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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