CLASS II Drug recall · Reported 1 May 2019 · FDA Enforcement Report
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1 syringe recalled
CMC Enterprise Pharmacy is recalling Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1 syringe, For Intradermal Use Only, Made by, distributed in North Carolina. The recall was initiated on 12 Apr 2019 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Lots: ED041902 Exp. 4/13/2019; ED051903 Exp. 04/14/2019; ED081902 Exp. 4/17/2019; ED091902 Exp. 4/18/2019; ED101903 Exp. 4/19/2019; ED111902 Exp. 4/20/2019
Quantity recalled 1135 syringes
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-1223-2019
FDA event ID 82620
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
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
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Questions about this recall
Why was it recalled? Lack of sterility assurance.
Which lots are affected? Lots: ED041902 Exp. 4/13/2019; ED051903 Exp. 04/14/2019; ED081902 Exp. 4/17/2019; ED091902 Exp. 4/18/2019; ED101903 Exp. 4/19/2019; ED111902 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 21 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 82620 This product is part of a recall event; the main page for the event is Chlorothiazide 100 mg syringe, Made by: Enterprise Pharmacy recalled .
Reported Class Recall Company Reason Where 1 May 2019 CLASS II Chlorothiazide 100 mg syringe, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II CeFAZolin 2 GM a) in NS recalled by CMC Enterprise Pharmacy CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Dexmedetomidine 400 mcg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Magnesium Sulfate 2 GM in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II CeFAZolin 3 gm 100 mg/mL syringe, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Lidocaine 1% - Sodium Bicarb 8.4% 10:1 syringe recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Oxytocin in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Heparin Pork in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Sodium Bicarbonate 150 mEq in D5W, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Phenylephrine 40 mg in 0.9% Sodium Chloride, 160 mcg/mL recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Magnesium Sulfate 6 GM in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Vancomycin 1250 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Vancomycin 2000 mg in 0.9% Sodium Chloride, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Clindamycin 900 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Lidocaine Buffered with J-Tip syringe, 10:1 recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Magnesium Sulfate 4 GM in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Alteplase 1 mg/mL in syringe, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Labetalol 20 mg/, 20 mg in syringe, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Phenylephrine 0.8 mg/ NS (0.08 mg/mL), (80 mcg/mL) syringe recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II CefTRIAXone 1 GM, 100 mg/mL syringe, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II NICARdipine 25 mg in NS Excel, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Norepinephrine 16 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Vancomycin 1500 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Sodium Citrate 4%, 40 mg/mL syringe, Flush Syringe, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Magnesium Sulfate 1 GM in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Vancomycin 1750 mg in 0.9% Sodium Chloride, Made recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Vancomycin 1000 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Phenylephrine 20 mg NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II CeFAZolin 1 GM a) in NS recalled by CMC Enterprise Pharmacy CMC Enterprise Pharmacy Sterility NC 1 May 2019 CLASS II Diltiazem 250 mg in NS, Made by: Enterprise Pharmacy recalled CMC Enterprise Pharmacy Sterility NC
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