FDA-Drug2017-12-13Class III

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

Elite Laboratories Inc.
Hazard

Failed Impurities/Degradation Specifications

Sold states
NY only
Affected count
1264 bottles
Manufactured in
165 Ludlow Ave, N/A, Northvale, NJ, United States
Products
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

Official notice

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

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