# FDA recall D-1641-2012

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

## Product

VITAMIN  K (PHYTONADIONE) 10MG/ML INJECTABLE	1 ML  	2 ML  	4 ML;  VITAMIN  K (PHYTONADIONE) 5MG/ML INJECTABLE	2 ML;  VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE	20 ML  	40 ML;  	  VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE	120 ML  	  	  	150 ML  	  	  	  	180 ML  	90 ML  	  VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12)  INJECTABLE	10 ML  	20 ML  	40 ML  VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 	60 ML  	  VITAMIN B COMPLEX -PF  (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE	40 ML  VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12)  INJECTABLE	10 ML  VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE	5 ML  VITAMIN B-COMPLEX 100*** (30ML)  INJECTABLE	30 ML  	  VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT	180 ML  	  	  	  	  	  	240 ML  	30 ML  	60 ML  VITAMIN D3  IN SESAME OIL 10,000 IU/ML INJECTABLE	60 ML  (23 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-1641-2012
- **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-1641-2012

## Citation

> AI Analytics. FDA recall D-1641-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1641-2012. Source: US FDA. Licensed CC0.

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