Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0483-2018·Announced 2018-02-28

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Hazard: cgmp-deviation
stability-data-deficiency

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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