Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0492-2018·Announced 2018-02-28

Fluconazole USP Recalled for Lack of Stability Data and Controls

American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

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 involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation regarding stability data rather than a confirmed contamination or injury.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding, available in 25g, 100g, and 1000g packages. The product is distributed nationwide within the USA and is intended for prescription use only.

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

Consumers and healthcare providers should stop using the affected lots and contact the recalling firm or their pharmacist for further instructions. The affected lots include specific expiration dates ranging from April 2020 to November 2021.

The recalled product

Product: Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Pharmaceutical Ingredient
Hazard: cgmp-deviation
stability-data-missing
Affected units: 106,200

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 (13)

Lot #: a) 051115-1
Exp. 4/30/2020
081017-1
exp 11/30/2021
122216-1
122216-2
Exp. 12/31/2020
b) 041017-1
Exp. 11/30/2021
051115-1
c) 041017-1
041017-2
exp. 12/31/2020

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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Same hazard · cgmp deviation