FDA recall D-0107-2018

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

NY only

Key facts

Status

Terminated

Initiation date

2017-11-13

Report date

2017-12-13

Termination date

2019-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0107-2018