Status
Terminated
Drug Enforcement D-1555-2012
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.
Classification
Class II
Report Date
August 22, 2012
Termination Date
August 15, 2014
Product Information
- Product description
- 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 VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 8 VIAL; LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 10 VIAL 14 VIAL 15 VIAL 17 VIAL 2 VIAL 20 VIAL 23 VIAL 25 VIAL 27 VIAL 3 VIAL 30 VIAL 33 VIAL 36 VIAL 5 VIAL 50 VIAL (35 DIFFERENT PRODUCTS)
- Product quantity
- 72 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-1555-2012
- Event ID
- 62443
- Recall initiation date
- May 21, 2012
- Center classification date
- August 10, 2012
- Code info
- 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
- More code info
- —