Home / Recalls / Elite Laboratories Inc. / D-0107-2018

D-0107-2018 Class III Terminated

Recalled by Elite Laboratories Inc. — Northvale, NJ

FDA drug recall D-0107-2018 was initiated by Elite Laboratories Inc. on Nov 13, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Mar 15, 2019). Affected quantity: 1264 bottles.

Recall Details

Product Type: Drugs
Report Date: Dec 13, 2017
Initiation Date: Nov 13, 2017
Termination Date: Mar 15, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1264 bottles

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

Distribution Pattern

NY only

Code Information

Lot #: P0910-017, Exp. 05/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0107-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.