# FDA recall D-1614-2012

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

## Product

RUBIDIUM 200MCG/ML INJECTABLE	30 ML  (1 PRODUCT)

## 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-1614-2012
- **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-1614-2012

## Citation

> AI Analytics. FDA recall D-1614-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1614-2012. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*