# FDA recall D-1634-2012

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

## Product

TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC	10 ML;  	  TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC	0.5 ML  	1.5 ML  	10 ML  	  	  	12 ML  	2 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	2.5 ML  	  	  	  	  	3 ML  	  	  	  	  	  	  	4 ML  	  	  	  	  	  	  	  	4.5 ML  	5 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	6 ML  	7.5 ML  	8 ML;  TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC	10 ML  	  	2.5 ML;  	  	  TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC	1 ML  	  	1.5 ML  	10 ML  	  	  	  	  	  	  	12 ML  	2 ML  	25 ML  	4 ML  	  	  	5 ML  	  	  	  	  	  	  	50 ML;  TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC	10 ML;  TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC	3 ML  	4.5 ML  	9 ML;  TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC	12 ML  (30 DIFFERENT PRODUCTS)

## 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-1634-2012
- **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-1634-2012

## Citation

> AI Analytics. FDA recall D-1634-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1634-2012. Source: US FDA. Licensed CC0.

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