PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 13, 2017 Initiated: November 13, 2017 #D-0107-2018

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

Details

Recalling Firm
Elite Laboratories Inc.
Units Affected
1264 bottles
Distribution
NY only
Location
Northvale, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Elite Laboratories Inc.. Units affected: 1264 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on December 13, 2017. Severity: Low. Recall number: D-0107-2018.