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.
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 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
- 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.
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