# FDA recall D-1643-2012

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

## Product

WATER BACT STERILE - (25X30ML)***  INJECTABLE	30 ML  	750 MLS;  WATER STERILE - USP (25X10ML)*  INJECTABLE	10 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	10 MLS  	  	100 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	100 MLS  	  	  	  	1000 ML  	  	  	  	  	  	  	110 ML  	  	120 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	130 ML  	  	130 MLS  	150   	150 ML  	  	  	  	  	  	  	150 MLS  	160 ML  	  	  	160 MLS  	20   	  	20 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	200 ML  	  	  	  	  	  	  	  	200 MLS  	  	2000 ML  	230 ML  	240 ML  	  	250 ML  	250 MLS  	30 ML  	  	  	  	  	  	  	  	  	  	  	  	  	30 MLS  	  	  	  	  	300   	300 ML  	  	  	  	300 MLS  	  	40 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	40 MLS  	  	400 ML  	  	400 MLS  	  	50   	  	  	50 ML  	  	  	  	  	  	50 MLS  	500 ML  	  	500 MLS  	60   	  	  	60 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-1643-2012
- **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-1643-2012

## Citation

> AI Analytics. FDA recall D-1643-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1643-2012. Source: US FDA. Licensed CC0.

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