Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories,...
FDA Recall #D-0107-2018 — Class III — November 13, 2017
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Recalling Firm
Elite Laboratories Inc. — Northvale, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1264 bottles
Distribution
NY only
Code Information
Lot #: P0910-017, Exp. 05/2019
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated