Drug Enforcement D-1631-2012

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.

Status

Terminated

Classification

Class II

Report Date

August 22, 2012

Termination Date

August 15, 2014

Product Information

Product description
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
Product quantity
64 units
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Location & Firm

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Address
1210 SW 33rd Avenue

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-1631-2012
Event ID
62443
Recall initiation date
May 21, 2012
Center classification date
August 10, 2012
Code info
Rx #'s: T0372867 T0387431 T0388104 T0389467 T0389651 T0389841 T0391671 T0394240 T0395182 T0395583 T0396607 T0397069 T0397176 T0398192 T0399822 T0399900 T0400079 T0400081 T0400293 T0400444 T0400658 T0400794 T0400806 T0400871 T0401635 T0401644 T0401957 T0402166 T0402388 T0402390 T0402553 T0402656 T0402943 T0403559 T0405372 T0405460 T0406116 T0406555 T0406565 T0406984 T0407064 T0407383 T0407394 T0407440 T0407793 T0408122 T0408306 T0408399 T0408744 T0409050 T0409093 T0409107 T0409169 T0409178 T0396714 T0394672 T0395926 T0394672 T0394672 T0398564 T0394672
More code info
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