Class II · Moderate risk
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe
Lack of assurance of sterility.
Bevacizumab & Dxm
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
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
BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 3 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.075ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.225 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 0.07 ML, 1.33 ML, 1.4 ML, 1.47 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.35 ML, 0.7 ML, 1.05 ML; BEVACIZUMAB & DXM, SDPF - (0.07ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.63 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECTABLE 1.8 ML, 2.7 ML; BEVACIZUMAB & DXM, SDPF - (0.09ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.18 ML, 0.27 ML, 0.45 ML, 1.08 ML, 13.5 ML,2.25 ML, 4.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 1 ML, 1.2 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML, 7.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 4 ML, 6 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/16MG/ML INJECTABLE 2 ML, 2.5 ML; BEVACIZUMAB & DXM, SDPF - (0.1ML SYRINGE, 31G, 5/16") 25MG/20MG/ML INJECTABLE 0.3 ML, 0.4 ML, 0.5 ML, 0.6 ML, 0.7 ML, 0.8 ML, 1 ML, 1.5 ML, 55.1 ML, 57.5 ML, 57.6 ML, 58 ML, 7.5 ML; BEVACIZUMAB & DXM, STSL (0.1ML SYRINGE, 30G, 1/2") 25MG/16MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB & TMC, SDPF - (0.075ML SYRINGE, 30G 1/2") 25MG/40MG/ML INJECTABLE 0.075 ML, 0.15 ML, 0.225 ML, 0.375 ML, 0.75 ML, 1.125 ML, 1.5 ML; BEVACIZUMAB & TMC, SDPF (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJECTABLE 0.45 ML, 0.75 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECTABLE 0.3 ML, 0.5 ML, 1 ML, 2 ML, 2.5 ML, 3 ML; BEVACIZUMAB & TMC, SDPF - (0.1ML SYRINGE, NO NEEDLE) 25MG/40MG/ML INJECTABLE 0.5 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.075ML SYRINGE, 30G, 1/2") 25MG/80MG/ML INJE 0.375 ML, 0.525 ML, 0.75 ML, 1.125 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.15ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJEC 0.6 ML, 0.75 ML, 0.9 ML, 1.05 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/20MG/ML INJECT 0.2 ML, 0.4 ML; BEVACIZUMAB & TMC, SDPF W/ STSL - (0.1ML SYRINGE, 30G, 1/2") 25MG/40MG/ML INJECT 0.6 ML, 1 ML; BEVACIZUMAB IN ARTIFICIAL TEARS 0.5% (5MG/ML) OPHTHALMIC 5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 27G, 1/2") 25MG/ML INJECTABLE 0.3 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0 MLS, 0.05 ML, 0.1 ML, 0.15 ML, 0.2 ML, 0.2 MLS, 0.25 ML, 0.25 MLS, 0.3 ML, 0.3 MLS, 0.35 ML, 0.36 ML, 0.4 ML, 0.45 ML, 0.5 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 1 ML, 1.2 ML, 1.25 ML, 1.5 ML,1.5 MLS, 1.75 ML, 1.8 ML, 10 ML, 15 ML, 2 ML, 2.25 ML, 2.5 ML, 2.5 MLS, 2.55 ML, 2.6 ML, 3 ML, 3.1 ML, 3.5 ML, 3.6 ML, 3.65 ML, 3.7 ML, 3.75 ML, 3.96 MLS, 4 ML, 4.5 ML, 5 ML, 5 MLS, 7 ML, 7.2 ML, 7.2 MLS, 7.25 ML, 7.3 MLS, 7.3 VIAL, 7.4 MLS, 7.5 ML; BEVACIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.1 ML, 0.15 ML, 0.2 ML, 0.25 ML, 0.3 ML, 0.35 ML, 0.4 ML, 0.5 ML, 0.55 ML, 0.6 ML, 0.65 ML, 0.7 ML, 0.75 ML, 0.8 ML, 0.85 ML, 0.9 ML, 1 ML, 1.1 ML, 1.2 ML, 1.25 ML, 1.5 ML, 1.75 ML, 10 ML, 12.25 ML, 12.5 ML, 13.5 ML, 15 ML, 17.5 ML, 2 ML, 2.25 ML, 2.5 ML, 2.6 ML, 3 ML, 3.5 ML, 3.75 ML, 4 ML, 4.5 ML, 5 ML, 5.05 ML, 6 ML, 6.25 ML, 6.35 ML, 7.5 ML, 8.75 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.2 ML, 2.88 ML; BEVACIZUMAB, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 1.5 ML, 1.8 ML, 2.4 ML, 3 ML, 3.6 ML, 4.8 ML, 6 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 1.75 ML; BEVACIZUMAB, SDPF - (0.07ML SYRINGE, 31G, 5/16") 25MG/ML INJECTABLE 0.14 ML, 0.21 ML, 1.75 ML, 3.5 ML, 4.2 ML, 5.6 ML, 7 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, 30G, 1/2") 25MG/ML INJECTABLE 0.08 ML; BEVACIZUMAB, SDPF - (0.08ML SYRINGE, NO NEEDLE) 25MG/ML INJECTABLE 0.08 ML, 0.16 ML, 0.24 ML, 0.32 ML, 0.48 ML, 16 ML, 8 ML; BEVACIZUMAB, SDPF - (0.1
Drug: Bevacizumab Category: Eye Drops & Ophthalmic
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1464-2012 · 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 Franck's Lab Inc., d.b.a. Franck's Compounding Lab
All 2012 recalls
Class II · Moderate risk
Ceftriaxone 1 gm/50 mL D5W
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class II · Moderate risk
Cefepime 2 gm/100 mL 0.9%NS
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class II · Moderate risk
Ceftriaxone 2 gm/100 mL D5W
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Class II · Moderate risk
Cefepime 1 gm/100 mL 0.9%NS
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
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