Status
Terminated
Drug Enforcement D-1571-2012
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
- METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE 0.8%/1.6%/1.6% INJECTABLE 180 ML 24 ML 240 ML 270 ML 30 ML 90 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE 25MG/50MG/50MG/ML INJECTABLE 120 ML 300 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE/B1/B2 0.8%/1.6%/1.6% INJECTABLE 60 ML (10 DIFFERENT PRODUCTS)
- Product quantity
- 22 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-1571-2012
- Event ID
- 62443
- Recall initiation date
- May 21, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #'s: 0391307 0387323 0394852 0390852 0391092 0391452 0391582 0387323 0387323 0402850 0409602 0388849 0395801 0401312 0362629 0393748 0405277 0391772
- More code info
- —