Leucovorin recall: Sterility Concern
LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG…
Why was Leucovorin 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. 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: 0403290 0405427 0382085 0403290 0382085 0405142 0391560 0391560 0382085 0362356 0362504 0376747 0398606 0405426 0362504 0362504 0376747 0402778 0405426 0395599 0395599 0405112 0406366 0388985 0391567 0396672 0405426 0395599 0398606 0360280 0385032 0390726 0402210 0398232 0360280 0362394 0393068 0403288 0360025 0369905 0379934 0393068 0402985 0403256 0399150 0360025 0372389 0399150 0402985 0399150 0403288 0372389 0393068 0398232 0360280 0362394 0393068 0398232
- Product
- LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG…
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Quantity
- 72 units
- Distribution
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
- Recall date
- August 22, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)