# FDA recall D-1497-2012

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

## Product

DEXAMETHASONE  SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML;  DEXAMETHASONE / LIDOCAINE  0.5%/3% INJECTABLE 30 MLS;  DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS)  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	40 ML  DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE	0.3 ML  	0.5 ML  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE	0.05 ML  	1 ML  	16 ML  	  	  	  	  	2 ML  	  	24 ML  	  	  	3 ML  	  	  	32 ML  	8 ML  	  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 4MG/ML (0.4%) INJECTABLE	0.4 ML  	2 ML  	3 ML  	  	5 ML  	6 ML  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 80MG/ML (8%) INJECTABLE	100 ML  	40 ML  	  	  DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 8MG/ML (800MCG/0.1ML) INJECTABLE	0.1 ML  DEXAMETHASONE SODIUM PHOSPHATE 40MG/ML INJECTABLE	50 ML  DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE	100 ML  	  	  	180 MLS  	  	240 MLS  	30 ML  	60 ML  DEXAMETHASONE SODI

## 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-1497-2012
- **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-1497-2012

## Citation

> AI Analytics. FDA recall D-1497-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1497-2012. Source: US FDA. Licensed CC0.

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