D-1560-2012 Class II Terminated
FDA drug recall D-1560-2012 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: 15 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
- 15 units
Product Description
LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE 10 ML 40 ML; LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 100 ML 1200 ML 300 ML 80 ML; LIDOCAINE/EPINEPHRINE 1%/0.00025% OPHTHALMIC 30 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE, P.F. (FOR DILUTION WITH BSS+) 1.71%/0.057% OPHTHALMIC 14 ML 7 ML (8 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: 0397942 0397942 0395256 0395256 0387634 0397219 0400108 0387634 0370170 0370170 0370170 0389690 0389690
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1560-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026