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CMC Enterprise Pharmacy
CMC Enterprise Pharmacy: 32 FDA recall reports
Every drug recall the FDA has published for CMC Enterprise Pharmacy. The fault, and how the agency graded it.
32Reports
0Class I
0Ongoing
2019-05-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1228-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 60 syringes
CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acre
D-1225-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- a) 1357 bags; b) 6895 syringes
Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E
D-1209-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 5678 bags
Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1214-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 6746 bags
CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1226-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 475 syringes
DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium C
D-1240-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 110 bags
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharma
D-1223-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- 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.
- Where it went
- NC
- How much
- 1135 syringes
Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy,
D-1222-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 40 syringes
Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Char
D-1219-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 3690 bags
Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suit
D-1229-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 87 bags
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J S
D-1233-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 100 bags
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Ac
D-1232-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 215 bags
Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1216-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 196 bags
Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Cha
D-1236-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 737 bags
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bl
D-1239-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 532 bags
Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Char
D-1210-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 1233 bags
Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharm
D-1221-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 705 syringes
Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1215-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 3007 bags
Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1220-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 97 syringes
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suit
D-1212-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 6667 syringes
Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres
D-1230-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 1310 syringes
CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite
D-1227-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 15 syringes
NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E
D-1217-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- 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 went
- NC
- How much
- 1783 bags
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, C
D-1218-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 2567 bags
Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Cha
D-1237-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- 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 went
- NC
- How much
- 715 bags
Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive
D-1234-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 40 syringes
Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E,
D-1213-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 2162 bags
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bl
D-1238-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 118 bags
Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Cha
D-1235-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 532 bags
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charl
D-1231-2019 · Class II · reported 2019-05-01 · Terminated
- Why it was recalled
- Lack of sterility assurance.
- Product
- Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Where it went
- NC
- How much
- 390 bags
Showing the 30 most recent of 32. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls