FDA Drug recall D-0107-2018
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class III recall of Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc by Elite Laboratories, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0107-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-13 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Elite Laboratories |
| Distribution | NY |
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
Failed Impurities/Degradation Specifications
Identifiers
| upc | 342806263013 |
|---|---|
| code_info | Lot #: P0910-017, Exp. 05/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0107-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.