# FDA recall D-1618-2012

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

## Product

SODIUM BICARBONATE 4% INJECTABLE	10 ML  	  	5 ML;  SODIUM BICARBONATE 8.4% INJECTABLE	150 ML  	50 ML  	5000 ML;  SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE	100 MLS  	250 ML;  SODIUM BICARBONATE, MDV 8.4% INJECTABLE	100 ML  	  	150 ML  	200 ML;  	  SODIUM CHLORIDE  0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE	25 VIAL  	40 ML;  SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION	1000 ML  	2500 ML;  SODIUM CHLORIDE 0.9%  BACTERIOSTATIC ** 0.9% INJECTABLE	30 MLS  	750 ML;  SODIUM CHLORIDE 0.9%  IRRIGATION (24X250ML)** 0.9% SOLUTION	250 ML;  SODIUM CHLORIDE 0.9%, 100ML I.V. BAG** 0.9% INJECTABLE	100 ML;  SODIUM TETRADECYL SO4 3% INJECTABLE	20 ML;  	  SODIUM TETRADECYL SULFATE  0.2 % INJECTABLE	30 ML  (20 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-1618-2012
- **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-1618-2012

## Citation

> AI Analytics. FDA recall D-1618-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1618-2012. Source: US FDA. Licensed CC0.

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