CLASS II Drug recall · Reported 1 May 2019 · FDA Enforcement Report
Vancomycin 1500 mg in NS, Made by: Enterprise Pharmacy recalled
CMC Enterprise Pharmacy is recalling Vancomycin 1500 mg in NS, 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-1237-2019
- 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
- Drug class
- Antibiotics
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
Vancomycin 1500 mg in NS 250 mL 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: ED041916 Exp. 4/13/2019; ED051916 Exp. 4/14/2019; ED081916 Exp. 4/17/2019; ED091916 Exp. 4/18/2019; ED101916 Exp. 4/19/2019; ED111914 Exp. 4/20/2019
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 Vancomycin recalls
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |