Cyclosporine USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Cyclosporine USP for prescription compounding due to CGMP deviations regarding stability data and expiration date 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a manufacturing deviation (lack of stability data) rather than a confirmed contamination or injury event, fitting the Moderate severity criteria for voluntary precautionary or labeling/quality control issues.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling specific lots of Cyclosporine USP, a prescription-only ingredient used for compounding. The product is packaged in 5g, 10g, 100g, and 500g containers and was distributed nationwide within the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its current container/closure system.
Healthcare providers and pharmacies should stop using the affected lots and contact the recalling firm for instructions on return or disposal. Patients should consult their healthcare provider regarding alternative sources for their medication.
The recalled product
- Product
- Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), 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
- 13,335
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) 062515-2
- Exp. 02/28/2019
- b) 062515-1
- 062515-2
- 052317B-2
- Exp. 01/31/2021
- c) 052317B-1
- 052317B-1
- 062515-1
- exp. 02/28/2019
- d) 052317B-1
- 062515-3
- exp. 02/28/2019.
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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