Recalls / Class II
Class IID-1609-2012
Product
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
- Affected lot / code info
- Rx #'s: 0370793 0400021 0388933 0400021 0397238 0397238
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
- 10 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-1609-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.