# FDA recall D-1512-2012

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

## Product

EDTA  DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML;  EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML; EDTA CALCIUM DISODIUM SOLUTION  2% OPHTHALMIC 5 ML; EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML; EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML;  EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML; EDTA DISODIUM IN NATURAL TEARS  1.5% OPHTHALMIC 5 ML; EDTA DISODIUM IN NATURAL TEARS  3% OPHTHALMIC 15 ML,	 30 ML (18 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 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-1512-2012
- **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-1512-2012

## Citation

> AI Analytics. FDA recall D-1512-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1512-2012. Source: US FDA. Licensed CC0.

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