# FDA recall D-1546-2012

> **Franck's Lab Inc., d.b.a. Franck's Compounding Lab** · Class II · drug recall initiated 2012-05-25.

## Product

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

## 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.

## Distribution

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies

## Key facts

- **Recall number:** D-1546-2012
- **Recalling firm:** Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-25
- **Report date:** 2012-08-22
- **Termination date:** 2014-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ocala, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1546-2012

## Citation

> AI Analytics. FDA recall D-1546-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1546-2012. Source: US FDA. Licensed CC0.

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