Class II · Moderate risk
Cathflo activase
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Alteplase 1 mg/mL 1 mL in 10 mL syringe
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
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.
Drug: Alteplase
- Recalling firm
- CMC Enterprise Pharmacy
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1220-2019 · 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 Alteplase recalls
See all
Class II · Moderate risk
cathflo activase
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class II · Moderate risk
Alteplase
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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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