# FDA recall D-1581-2012

> **Franck's Lab Inc., d.b.a. Franck's Compounding Lab** · Class II · drug recall initiated 2012-05-21.

## Product

MITOMYCIN 1MG/ML SOLUTION	160 ML  	  	  	  	  	  	  	  	  	  	  	40 ML  	  	  	  	  	  	80 ML;  	  	  	  	  MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC	0.5 ML  	  	  	  	  	1 ML  	  	  	  	  	  	  	  	1.5 ML  	  	  	  	  	10 ML  	  	  	  	  	  	  	  	12.5 ML  	2 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	2.5 ML  	  	  	3 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	30 ML  	4 ML  	  	  	  	5 ML  	  	  	  	  	  	  	  	  	  	  	  	6 ML  	  	  	  	7 ML;  MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC	2 ML  	3 ML  	  	  	  	4 ML  	  	6 ML  MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC	2 ML  	3 ML  	  	  	4 ML  	  	5 ML;  MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC	1 ML  	  	  	  	  	  	10 ML  	  	  	  	  	  	  	  	  	12 ML  	  	  	2 ML  	  	  	  	20 ML  	  	3 ML  	  	  	  	  	3.6 ML  	  	  	4 ML  	  	  	  	5 ML  	  	  	  	5.4 ML  	6 ML  	  	  	  	  	  	7.2 ML;  MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC	1.5 ML  	10 ML  	  	

## 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. 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, West Indies

## Key facts

- **Recall number:** D-1581-2012
- **Recalling firm:** Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-21
- **Report date:** 2012-08-22
- **Termination date:** 2014-08-15

- **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-1581-2012

## Citation

> AI Analytics. FDA recall D-1581-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1581-2012. Source: US FDA. Licensed CC0.

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