drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 K

Recalled Product

INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Rx #'s: 0392321 0394025 0388514 0401919 0350642 0394025 0388514 0394025 0388514 0390732 0390733 0390734 0390735 0390736 0390737 0390738 0380350 0368327 0374556 0367241 0389528 0387672 0387673 0388017 0388019 0388022 0388506 0388512 0388515 0392608 0392615 0392616 0392619 0392621 0396198 0396215 0396216 0396229 0396231 0399438 0399439 0399442 0399445 0403009 0403010 0403011 0403012 0403013 0406259 0406260 0406262 0406344 0407979 0407983 0407994 0407995 0407997 0389528 0380350 0391097 0391097 0391097 0394711 0394711 0396280 0396282 0401229 0401451 0403261 0403264 0403265 0403266 0406344 0367241 0391097 0360638 0360913 0370332 0374556 0367241 0368572 0374556 0390415 0396119 0381037 0381037 0409349 0381037 0407487 0369244 0398000 0400203 0369244 0401228 0365406 0381433 0382639 0397201 0408640 0398000 0366257 0366257 0381433 0387899 0408486 0381433 0387899 0397201 0401228 0382639 0403456 0358087 0394872 0401833 0403472 0392320 0360357
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