Indocyanine Green - KIT 15mg Injectable 1 KIT recall: Sterility Concern
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…
Why was Indocyanine Green - KIT 15mg Injectable 1 KIT recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 134 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)