D-0107-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 13, 2017
- Initiation Date
- November 13, 2017
- Termination Date
- March 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