• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

  • Print
  • Share
  • E-mail
-

Product Detail

Product Description TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12 ML 2 ML 2.5 ML 3 ML 4 ML 4.5 ML 5 ML 6 ML 7.5 ML 8 ML; TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC 10 ML 2.5 ML; TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC 1 ML 1.5 ML 10 ML 12 ML 2 ML 25 ML 4 ML 5 ML 50 ML; TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC 10 ML; TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 3 ML 4.5 ML 9 ML; TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 12 ML (30 DIFFERENT PRODUCTS)
Recall Number D-1634-2012
Classification Class II
Code Info Rx #'s: 0396447 0391904 0396678 0393251 0400335 0402500 0352474 0368241 0387963 0394942 0402089 0394942 0400335 0352474 0368241 0393251 0395043 0368241 0393251 0403936 0409994 0391904 0349660 0368241 0388163 0390614 0391904 0401994 0402332 0402500 0393985 0368241 0403168 0402227 0403032 0395193 0396679 0397454 0396679 0387480 0387514 0397147 0401881 0405105 0409255 0397147 0403630 0397147 0401846 0387647 0390992 0397147 0403742 0402848 0402848 0402848 0399288
Product Distributed Qty 102 units
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.

Event Detail

Event Id 62443
Product Type Drugs
Status Ongoing
Recalling Firm Franck's Lab Inc., d.b.a. Franck's Compounding Lab
City Ocala
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
-
-