American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
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, or exposure to, a violative product may 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 safety hazard like a structural defect or known pathogen.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding, packaged in 1g, 10g, and 25g quantities. The product is packed by American Pharmaceutical Ingredients, LLC, located in Waterford, Michigan, and was distributed nationwide within the USA. The recall involves specific lots with expiration dates of 11/30/2020.
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 dates for the product in its container/closure system. This deficiency raises concerns about the product's stability and quality over time.
Healthcare professionals and pharmacies that have received this product should stop using it and contact the recalling firm for instructions on return or disposal. Patients who have been prescribed this specific product should consult their healthcare provider regarding alternative treatments or further instructions.
The recalled product
- Product
- Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) 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
- 1,638
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 (6)
- Lot #: a) 012016-2
- Exp. 11/30/2020
- b) 012016-1
- c) 012016-1
- 012016-2
- Exp.11/30/2020
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.
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