Drug Enforcement D-1483-2012

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 because 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 13, 2014

Product Information

Product description
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED 4,000 UNIT/40MCG/ML KIT 1 KIT, 2 KIT, 3 KIT; CHORIONIC GONADOTROPIN + B12, LYOPHILIZED (HCG) 4,000 UNIT VIAL INJECTABLE 1 VIAL, 12 VIALS; CHORIONIC GONADOTROPIN KIT 5,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN** KIT 10,000 UNIT VIAL INJECTABLE 1 KIT; CHORIONIC GONADOTROPIN, HUMAN - MINI 250 UNITS TROCHE 30 TROCHE, 45 TROCHE, 50 TROCHE, 60 TROCHE, 80 TROCHE; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 1,000 UNIT VIAL INJECTABLE 30 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL INJECTABLE 1 VIAL, 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 2 VIALS, 20 VIAL, 3 VIAL, 5 VIAL, 6 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 125 UNIT VIAL (UNIT DOSE) INJECTABLE 10 VIAL, 14 VIAL, 15 VIAL, 2 VIAL, 24 VIAL, 28 VIAL, 28 VIALS, 7 VIAL, 7 VIALS; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 2,500 UNIT VIAL INJECTABLE 5 VIAL; CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 200 UNIT VIAL (UNIT DOSE) INJECTABLE 22 VIAL, 25 VIAL, 8 VIAL (40 DIFFERENT PRODUCTS)
Product quantity
193 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and 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-1483-2012
Event ID
62416
Recall initiation date
May 25, 2012
Center classification date
August 10, 2012
Code info
Rx #'s: 0389332 0388230 0362007 0362537 0369266 0369759 0376765 0376766 0378972 0381347 0381668 0383006 0384070 0387408 0387842 0387873 0388522 0388825 0389034 0389038 0389347 0389746 0389824 0389913 0390210 0390265 0390267 0390404 0390481 0391083 0391374 0391789 0392302 0392329 0393161 0393238 0393733 0393734 0394038 0396204 0396253 0396951 0397068 0397814 0397816 0398167 0398775 0398809 0399039 0399168 0400419 0401454 0401456 0401717 0402440 0402443 0403637 0377693 0382907 0389892 0390269 0393418 0397085 0397984 0398761 0401192 0401453 0401702 0402969 0403042 0353856 0380968 0389852 0396383 0396985 0397369 0405720 0409461 0400111 0392017 0405577 0405591 0407190 0390553 0410265 0393727 0394656 0399169 0403590 0392209 0392212 0392214 0392215 0392217 0394902 0395795 0395799 0395800 0395880 0395884 0395885 0398821 0399797 0403933 0405574 0405578 0405607 0405608 0406394 0410495 0394528 0395347 0392045 0393681 0393682 0394381 0396742 0396763 0401783 0401785 0405205 0404805 0397298 0398209 0401610 0404696 0406424 0408386 0408794 0409008 0409330 0409500 0409511 0410093 0410179 0410202 0410327 0394569 0397231 0400352 0400360 0410043 0410045 0410046 0394569 0394569 0407106 0407854 0409176 0408788 0394569 0405634 0394765 0405634 0392318 0394569 0373437 0381856 0387413 0397985 0398350 0394512 0401471 0404558 0393614 0397800 0387413 0406999 0397800 0397822 0388830 0380110 0407385 0380110
More code info
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