Cyclosporine Capsules Recalled for Impurity Specification Failures
Amerisource Health Services is recalling 454 cartons of Cyclosporine Capsules, 100 mg, due to failed impurity specifications.
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 temporary or medically reversible adverse health consequence. The hazard is a quality control failure (impurities) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or specification failures.
Plain-English summary
Amerisource Health Services is recalling 454 cartons of CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons. The product is distributed by American Health Packaging in Columbus, OH, and is available nationwide. The specific lot affected is 154527, with an expiration date of 4/30/2017.
The recall was initiated because the product failed impurities and degradations specifications. Specifically, the product produced out-of-specification results for Maximum Unknown Impurities and Total Impurities.
Consumers and healthcare providers should check their inventory for the specific NDC 68084-921-25 and Lot 154527. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- CYCLOSPORINE (CYCLOSPORINE)
- Brand
- CYCLOSPORINE
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Drug
- Affected units
- 454
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 (2)
- Lot 154527
- exp 4/30/2017
Distribution
Distributed nationwide across the United States.
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