US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Bevacizumab & Dxm, Sdpf - (0.06ml Syringe, 31g, 5/16") 25mg/100mg/Ml Injectable 0.72 Ml…

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.

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

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

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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