Recalls / Class II
Class IID-1563-2012
Product
LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)
- Affected lot / code info
- Rx #'s: 0387816 0387171 0387357 0401493 0372169 0401493 0401493
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
- 8 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-1563-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.