# FDA recall D-1558-2012

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

## Product

LIDOCAINE HCL  (STERILE) 4% JELLY	120 ML  	  	  	  	  	30 ML;  	  LIDOCAINE HCL  4% SOLUTION	200 ML  	300 ML  	500 ML  	  	  	  	600 ML;  	  LIDOCAINE HCL 1% INJECTABLE	100 ML  	  	  	  	  	1000 ML  	  	  	  	  	  	  	  	  	1200 ML  	  	  	  	  	  	  	  	  	  	  	1250 ML  	  	150 ML  	  	  	  	  	1500 ML  	  	180 ML  	  	20 ML  	200 ML  	  	  	  	  	2000 ML  	240 ML  	250 ML  	  	  	  	2500 ML  	  	300 ML  	  	  	  	  	  	350 ML  	360 ML  	  	400 ML  	480 ML  	  	50 ML  	500 ML  	  	  	  	  	  	  	  	  	  	  	60 ML  	600 ML  	  	  	  	720 ML  	  	750 ML  	7500 ML  	90 ML;  LIDOCAINE HCL 10% INJECTABLE	1000 ML;  LIDOCAINE HCL IN BSS - P.F. OPHTHALMIC 1% INJECTABLE	30 ML;  LIDOCAINE HCL W/EPI (25X30ML) MDV *** 1%-1:100000 INJECTABLE	150 MLS  	180 MLS  	50 VIALS;  LIDOCAINE HCL, AQUEOUS  2% INJECTABLE	100 ML  	  	  	  	1000 ML  	  	  	120 ML  	1200 GM  	1200 ML  	  	  	  	  	  	  	  	150 ML  	  	1500 ML  	20 ML  	200 ML  	  	2000 ML  	240 ML  	250 ML  	  	  	  	  	2500 ML  	  	300 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-1558-2012
- **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-1558-2012

## Citation

> AI Analytics. FDA recall D-1558-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1558-2012. Source: US FDA. Licensed CC0.

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