Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
BevaDex (bevacizumab)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility.
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
BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.
Drug: Bevacizumab
- Recalling firm
- Bella Pharmaceuticals, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1161-2017 · 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 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 Bella Pharmaceuticals, Inc.
All 2017 recalls
Class II · Moderate risk
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes
Lack of Assurance of Sterility.
Class II · Moderate risk
Fluorescein Sodium
Lack of Assurance of Sterility.
Class II · Moderate risk
Sodium Bicarbonate 8.4%
Lack of Assurance of Sterility.
Class II · Moderate risk
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Lack of Assurance of Sterility.
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