D-1622-2012 Class II Terminated
FDA drug recall D-1622-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 21, 2012 and is designated Class II. 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… The recall status is terminated (terminated Aug 15, 2014). Affected quantity: 26 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2012
- Initiation Date
- May 21, 2012
- Termination Date
- Aug 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
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.
Distribution Pattern
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1622-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026