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

FDA recall notice · announced December 13, 2017 · Elite Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: NY only
Lot/code information: Lot #: P0910-017, Exp. 05/2019
Quantity: 1264 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0107-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.