Recalls / Class II
Class IID-1622-2012
Product
TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
- Affected lot / code info
- Rx #'s: 0387030 0388227 0388955 0389127 0389637 0389994 0391604 0391610 0394004 0394519 0394522 0396467 0396470 0397420 0397616 0399672 0400482 0401216 0401503 0402138 0403400 0403543 0404150 0405978 0362094 0382304
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
- 26 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-1622-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.