CLASS III Drug recall · Reported 17 Jul 2013 · FDA Enforcement Report
Nicardipine Hydrochloride Injection 25 mg recalled
West-ward Pharmaceutical is recalling Nicardipine Hydrochloride Injection 25 mg/ (2.5 mg/mL) single-use vials, distributed nationwide in the US. The recall was initiated on 13 May 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-691-2013
- FDA event ID
- 65287
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 May 2013
- FDA classified
- 11 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 May 2013 | Recall initiated by company | |
| 11 Jul 2013 | Classified by FDA | +59 days |
| 17 Jul 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Which lots are affected?
Lot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 2 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
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Other Nicardipine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cardene IV (Nicardipine Hydrochloride) recalled by Baxter HealthcareCardene Iv | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | Nationwide |
| Drug | CLASS II | niCARdipine Hydrochloride Injection, USP, 25 mg recalledNicardipine Hydrochloride | American Regent | Sterility | UT |