Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0497-2018·Announced 2018-02-28

FDA Recalls Itraconazole USP for Prescription Compounding Due to Stability Data Issues

American Pharmaceutical Ingredients LLC is recalling Itraconazole USP for prescription compounding because it lacks stability data to support its expiration dates.

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 is typically associated with a temporary or medically reversible adverse health consequence. 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 minor labeling or quality errors without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Itraconazole USP (Micronized) for prescription compounding, packed by American Pharmaceutical Ingredients LLC. The product is available in 10g, 25g, 100g, and 1000g packages and is distributed nationwide within the United States.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the stability data and controls necessary to support the assigned retest or expiration dates for the product in its current container/closure system.

Healthcare professionals and patients should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions. The affected lots include specific expiration dates ranging from April 30, 2020, to July 31, 2021, as detailed in the recall notice.

The recalled product

Product: Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI…
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: stability-data-deficiency
expiration-date-uncertainty
Affected units: 52,000

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 (14)

Lot #: a) 061515-1
Exp. 04/30/2020
b) 080316-1
Exp. 06/30/2021
052317C-1
Exp 02/28/2022
061515-1
c) 061515-1
080316-1
091216-1
Exp. 07/31/2021
d) 061515-1
061515-2
exp. 04/30/2020

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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