FDA Drug recall D-691-2013
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, N…
- FDA Drug
- Class III
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class III recall of Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, N… by West Ward Pharmaceutical, citing failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-691-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-13 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
Product
Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Reason
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Identifiers
| ndc | 0143-9689-01 |
|---|---|
| ndc | 0143-9689-10 |
| ndc | 0143-9633-01 |
| ndc | 0143-9633-10 |
| ndc | 0143-9634-01 |
| ndc | 0143-9634-10 |
| code_info | Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014 |
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-691-2013%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.