# FDA recall D-1466-2012

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

## Product

BIMIX   30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX   30MG / 5MG INJECTABLE 10 ML; BIMIX   9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX  15MG / 1MG INJECTABLE 10 ML; BIMIX  18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX  18MG / 1MG INJECTABLE 5 ML; BIMIX  20MG / 0.75MG INJECTABLE 5 ML; BIMIX  26MG/1MG/ML INJECTABLE 10 ML; BIMIX  26MG/2MG/ML INJECTABLE 20 ML; BIMIX  30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX  30MG / 1.5MG INJECTABLE 5 ML; BIMIX  30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS,	12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX  9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM  9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM  9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG

## 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-1466-2012
- **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-1466-2012

## Citation

> AI Analytics. FDA recall D-1466-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1466-2012. Source: US FDA. Licensed CC0.

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