Elite Laboratories Recalls Isradapine Capsules Due to Impurity Failures
Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg in New York due to failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which the rubric associates with minor labeling errors or low-risk contamination, typically resulting in a score of 1 or 2. Given the nature of impurity failures, a score of 2 is appropriate.
Plain-English summary
Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg, 100-count bottles, which are prescription-only. The product is identified by NDC 42806-263-01 and UPC 342806263013. The specific lot affected is P0910-017, with an expiration date of 05/2019.
The recall was initiated because the product failed impurities and degradation specifications. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed only in New York. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
- Manufacturer
- Elite Laboratories Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,264
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 #: P0910-017
- Exp. 05/2019
Distribution
Distributed in 1 state:
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