Indocyanine Green - Kit 15mg Injectable 1 Kit

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

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

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-1546-2012

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.

Other Indocyanine recalls

See all

Class II · Moderate risk Ongoing Apr 26, 2023

IC-Green

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0812-2023

Class III · Low risk Terminated Apr 20, 2017

IC-Green

Reason Product is being recalled due to low pH value.

Akorn, Inc. NDC 17478-701-02 D-0697-2017

Class II · Moderate risk Terminated Sep 21, 2016