INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT

Recall Number: D-1546-2012

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

Classification: Class II

Status: Terminated

Report Date: 20120822

Initiation Date: 20120525

Termination Date: 20140813

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.

INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT