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

Recall Number: D-0107-2018

Firm: Elite Laboratories Inc.

Classification: Class III

Status: Terminated

Report Date: 20171213

Initiation Date: 20171113

Termination Date: 20190315

Failed Impurities/Degradation Specifications

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