Recalls / Class II
Class IID-1589-2012
Product
ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
- Affected lot / code info
- Rx #'s: 0403973 0408102 0403973 0409770 0403973 0403973 0400158 0400507 0400959 0402186 0398525 0400507 0400959 0398520 0400995 0400997
Why it was 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.
Recalling firm
- Firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1210 SW 33rd Avenue, Ocala, Florida 34474-5138
Distribution
- Quantity
- 16 units
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Timeline
- Recall initiated
- 2012-05-21
- FDA classified
- 2012-08-10
- Posted by FDA
- 2012-08-22
- Terminated
- 2014-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1589-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.