FDA recall D-1643-2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab · Class II · drug

Product

WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML 110 ML 120 ML 130 ML 130 MLS 150 150 ML 150 MLS 160 ML 160 MLS 20 20 ML 200 ML 200 MLS 2000 ML 230 ML 240 ML 250 ML 250 MLS 30 ML 30 MLS 300 300 ML 300 MLS 40 ML 40 MLS 400 ML 400 MLS 50 50 ML 50 MLS 500 ML 500 MLS 60 60 ML

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1643-2012