Nicardipine Hydrochloride Injection 25 mg/10 mL — Class III drug recall D-691-2013
Terminated recall by West-ward Pharmaceutical Corp., reported 2013-07-17, distributed nationwide. Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Deriva
| Recall number | D-691-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-07-11 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2015-03-17 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00143-9633, 00143-9633-01, 00143-9633-10, 00143-9634, 00143-9634-01, 00143-9634-10, 00143-9689, 00143-9689-01, 00143-9689-10 |
| Lot numbers | PLNJ1201, PLNJ1202 |
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 for recall
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-691-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.