Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Norepinephrine 16 mg in NS 250 mL bag
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Drug: Epinephrine
- Recalling firm
- CMC Enterprise Pharmacy
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1218-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Epinephrine recalls
See all
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Other recalls by CMC Enterprise Pharmacy
All 2019 recalls
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1500 mg in NS 250 mL bag
Lack of sterility assurance.
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