Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
Avastin (Bevacizumab)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Non-Sterility: Product tested positive for bacterial contamination.
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
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Drug: Bevacizumab
- Recalling firm
- Pacifico National, Inc. dba AmEx Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0870-2016 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bevacizumab recalls
See all
Class II · Moderate risk
bevacizumab
Lack of Assurance of Sterility
Class II · Moderate risk
Bevacizumab
Lack of Sterility Assurance
Class II · Moderate risk
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Lack of Assurance of Sterility
Class III · Low risk
Bevacizumab 2.5 mg/0.1 mL
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Other recalls by Pacifico National, Inc. dba AmEx Pharmacy
All 2015 recalls
Class II · Moderate risk
Bevacizumab
Lack of assurance of sterility.
Class II · Moderate risk
Bevacizumab
Lack of assurance of sterility.
Class II · Moderate risk
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal…
Defective Delivery System: difficult to express
Class I · High risk
Avastin (Bevacizumab)
Non-Sterility: Product tested positive for bacterial contamination.
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