# FDA recall D-1482-2012

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

## Product

CEFTAZIDIME OPHTHALMIC, P.F. 22.5MG/ML (2.25%) OPHTHALMIC 1 ML, 2ML, 2 MLS, 6 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  CEFTAZIDIME, LYOPHILIZED, OPHTHALMIC KIT 2.25% KIT	1 KIT  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	12 KIT  	16 KIT  	2 KIT  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	2 KITS  	  	20 KIT  	  	  	  	3 KIT  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	3 KITS  	  	4 KIT  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	4 KITS  	  	4 VIALS  	5 KIT  	  	  	6 KIT  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	6 VIAL  	8 KIT  	  CEFTAZIDIME, SDPF - (0.2ML SYRINGE, 30G, 1/2") 2.25% INJECTABLE	0.2 ML  	  	  	  	  	0.4 ML  	  	  	0.6 ML  	0.8 ML  	  	  	1.2 ML  	  	  	1.6 ML (25 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-1482-2012
- **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-1482-2012

## Citation

> AI Analytics. FDA recall D-1482-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1482-2012. Source: US FDA. Licensed CC0.

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