Product: BIMIX   30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX   30MG / 5MG INJECTABLE 10 ML; BIMIX   9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX  15MG / 1MG INJECTABLE 10 ML; BIMIX  18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX  18MG / 1MG INJECTABLE 5 ML; BIMIX  20MG / 0.75MG INJECTABLE 5 ML; BIMIX  26MG/1MG/ML INJECTABLE 10 ML; BIMIX  26MG/2MG/ML INJECTABLE 20 ML; BIMIX  30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX  30MG / 1.5MG INJECTABLE 5 ML; BIMIX  30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS,
Reason for recall: 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.
Recall initiated: 20120525
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated