CLASS II Drug recall · Reported 1 May 2019 · FDA Enforcement Report
NICARdipine 25 mg in NS Excel, Made by: Enterprise Pharmacy recalled
CMC Enterprise Pharmacy is recalling NICARdipine 25 mg in NS Excel, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg, distributed in North Carolina. The recall was initiated on 12 Apr 2019 and the FDA has classified it as Class II.
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-1217-2019
- FDA event ID
- 82620
- Recalling firm
- CMC Enterprise Pharmacy, Charlotte, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2019
- FDA classified
- 23 Apr 2019
- Reported
- 1 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 12 Apr 2019 | Recall initiated by company | |
| 23 Apr 2019 | Classified by FDA | +11 days |
| 1 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Where it was distributed
NC
Questions about this recall
Why was it recalled?
Lack of sterility assurance.
Which lots are affected?
Lots: EA161909 Exp. 4/16/2019; EA211907 Exp. 4/21/2019; EB041906 Exp. 5/5/2019; EB111908 Exp. 5/12/2019; EB181907 Exp. 5/19/2019; EB251910 Exp. 5/26/2019; EC111908 Exp. 6/9/2019; EC201909 Exp. 6/18/2019; EC261909 Exp. 6/24/2019; EC271919 Exp. 6/25/2019
Where was it sold?
NC
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
31 other products · FDA event 82620This product is part of a recall event; the main page for the event is Chlorothiazide 100 mg syringe, Made by: Enterprise Pharmacy recalled.
More recalls from CMC Enterprise Pharmacy
All 32Other 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 |