MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)

Recall Number: D-1579-2012

Firm: Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120521

Termination Date: 20140815

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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS)