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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

CMC Enterprise Pharmacy: Various Compounded Injectables Recalled for Lack of Sterility Assurance

Agency Publication Date: April 22, 2019
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Summary

CMC Enterprise Pharmacy is recalling approximately 44,124 units of various compounded sterile medications, including bags and syringes of antibiotics, sedatives, and anesthetics, because they may not be sterile. The lack of sterility assurance was identified following a voluntary firm-initiated recall of products produced at their Charlotte, North Carolina facility. These medications were distributed primarily to healthcare facilities in North Carolina between April and September 2019.

Risk

Administering a non-sterile injectable medication directly into the bloodstream or body cavity can cause serious, life-threatening infections such as sepsis or meningitis. While no injuries have been reported to date, the lack of sterility assurance means the products could contain bacteria or fungi that the body cannot fight effectively.

What You Should Do

  1. Immediately check your medical supplies for any of the 32 affected medication types from Enterprise Pharmacy, including Dexmedetomidine, Magnesium Sulfate, Vancomycin, and CeFAZolin, produced at 4400 Golf Acres Drive, Charlotte, NC.
  2. Verify the lot numbers and expiration dates on the product labels against the extensive list of affected lots, which include codes like EA141908 (Exp 4/14/2019), EB041905 (Exp 5/6/2019), and EC251910 (Exp 9/21/2019).
  3. Stop using any affected medication bags or syringes immediately and quarantine the products to prevent administration to patients.
  4. Contact your healthcare provider or pharmacist immediately if you have received any of these medications and are experiencing unusual symptoms or signs of infection.
  5. Return any unused or expired products from the affected lots to the pharmacy where they were obtained for a refund and further instructions.
  6. For more information, contact CMC Enterprise Pharmacy at 4400 Golf Acres Dr, Charlotte, NC or call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consumers should stop using the products and contact their dispensing pharmacy for return instructions and a full refund.

Affected Products

Product: Dexmedetomidine 400 mcg in NS (100 mL bag)
Model:
D-1209-2019
Lot Numbers:
EA141908
EA171909
EA211906
EA251908
EB041905
EB071907
EB151909
EC041906
EC111907
EC181908
EC201907
Date Ranges: Exp. 4/14/2019, Exp. 4/17/2019, Exp. 4/21/2019, Exp. 4/25/2019, Exp. 5/6/2019, Exp. 5/8/2019, Exp. 5/16/2019, Exp. 6/2/2019, Exp. 6/9/2019, Exp. 6/16/2019, Exp. 6/18/2019
Product: Clindamycin 900 mg in NS (50 mL bag)
Model:
D-1210-2019
Lot Numbers:
EA211905
EB061906
EB131907
EB221907
EC251909
Date Ranges: Exp. 4/21/2019, Exp. 5/7/2019, Exp. 5/14/2019, Exp. 5/23/2019, Exp. 6/23/2019
Product: Diltiazem 250 mg in NS (250 mL bag)
Model:
D-1211-2019
Lot Numbers:
EA161906
EA181906
EA231907
EA241907
EB061907
EB201907
EC181909
Date Ranges: Exp. 4/16/2019, Exp. 4/18/2019, Exp. 4/23/2019, Exp. 4/24/2019, Exp. 5/7/2019, Exp. 5/21/2019, Exp. 6/16/2019
Product: Labetalol 20 mg/4 mL (4 mL syringe)
Model:
D-1212-2019
Lot Numbers:
EA241908
EB011905
EB081909
EB151910
EB251909
EC061907
EC151906
Date Ranges: Exp. 4/24/2019, Exp. 5/2/2019, Exp. 5/9/2019, Exp. 5/16/2019, Exp. 5/26/2019, Exp. 6/4/2019, Exp. 6/13/2019
Product: Magnesium Sulfate 1 GM in NS (50 mL bag)
Model:
D-1213-2019
Lot Numbers:
EK051810
EK281808
EL101810
EL141807
EA081910
EA161908
EA301908
EB111907
EC041907
Date Ranges: Exp. 5/4/2019, Exp. 5/27/2019, Exp. 6/8/2019, Exp. 6/12/2019, Exp. 7/7/2019, Exp. 7/15/2019, Exp. 7/29/2019, Exp. 8/10/2019, Exp. 8/31/2019
Product: Magnesium Sulfate 2 GM in NS (50 mL bag)
Model:
D-1214-2019
Lot Numbers:
EK021807
EK021807A
EK261807
EK271808
EK301811
EL261811
EL281808
EA031908
EA111908
EA181907
EA281908
EB071908
EB201909
EC151907
Date Ranges: Exp. 5/1/2019, Exp. 5/25/2019, Exp. 5/26/2019, Exp. 5/29/2019, Exp. 6/24/2019, Exp. 6/26/2019, Exp. 7/2/2019, Exp. 7/10/2019, Exp. 7/17/2019, Exp. 7/27/2019, Exp. 8/6/2019, Exp. 8/19/2019, Exp. 9/11/2019
Product: Magnesium Sulfate 4 GM in NS (50 mL bag)
Model:
D-1215-2019
Lot Numbers:
EK131812
EL051809
EL111808
EL141808
EA031909
EA141909
EA311910
EB061909
EC121909
EC251910
Date Ranges: Exp. 5/12/2019, Exp. 6/3/2019, Exp. 6/9/2019, Exp. 6/12/2019, Exp. 7/2/2019, Exp. 7/13/2019, Exp. 7/30/2019, Exp. 8/5/2019, Exp. 9/8/2019, Exp. 9/21/2019
Product: NICARdipine 25 mg in NS (250 mL EXCEL bag)
Model:
D-1217-2019
Lot Numbers:
EA161909
EA211907
EB041906
EB111908
EB181907
EB251910
EC111908
EC201909
EC261909
EC271919
Date Ranges: Exp. 4/16/2019, Exp. 4/21/2019, Exp. 5/5/2019, Exp. 5/12/2019, Exp. 5/19/2019, Exp. 5/26/2019, Exp. 6/9/2019, Exp. 6/18/2019, Exp. 6/24/2019, Exp. 6/25/2019
Product: Vancomycin 1000 mg in NS (250 mL bag)
Model:
D-1235-2019
Lot Numbers:
ED041918
ED051918
ED081918
ED091918
ED101918
ED111916
Date Ranges: Exp. 4/13/2019, Exp. 4/14/2019, Exp. 4/17/2019, Exp. 4/18/2019, Exp. 4/19/2019, Exp. 4/20/2019
Product: DelNido Cardioplegia (1000 mL bag)
Model:
D-1240-2019
Lot Numbers:
ED041909
ED111907
Date Ranges: Exp. 4/13/2019, Exp. 4/20/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82620
Status: Resolved
Manufacturer: CMC Enterprise Pharmacy
Sold By: CMC Enterprise Pharmacy; Hospitals; Healthcare Facilities
Manufactured In: United States
Units Affected: 32 products (5678 bags; 1233 bags; 1475 bags; 6667 syringes; 2162 bags; 6746 bags; 3007 bags; 196 bags; 1783 bags; 2567 bags; 3690 bags; 97 syringes; 705 syringes; 40 syringes; 1135 syringes; a) 150 bags; b)1369 syringes; a) 1357 bags; b) 6895 syringes; 475 syringes; 15 syringes; 60 syringes; 87 bags; 1310 syringes; 390 bags; 215 bags; 100 bags; 40 syringes; 532 bags; 737 bags; 715 bags; 118 bags; 532 bags; 110 bags)
Distributed To: North Carolina
Agency Last Updated: April 23, 2019

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.