Status
Terminated
Drug Enforcement D-1468-2012
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Classification
Class II
Report Date
August 22, 2012
Termination Date
August 13, 2014
Product Information
- Product description
- BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.5MG/ML OPHTHALMIC 1.5 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 1% OPHTHALMIC 0.5 ML,1 ML,1.5 ML, 2 ML, 3 ML, 5 ML, 6 ML, 8 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.025% OPHTHALMIC 2.5 ML, 5 ML; BRILLIANT BLUE G, P.F. (STSL) (0.5ML SYRINGE) 0.15% OPHTHALMIC 2.5 ML; BRILLIANT BLUE G, P.F. 0.25% OPHTHALMIC 1 ML, 10 ML, 20 ML; BRILLIANT BLUE G, P.F. 0.5% OPHTHALMIC 1 ML, 10 ML, 20 ML, 5 ML; BRILLIANT BLUE G, P.F. 1% OPHTHALMIC 10 ML, 12 ML, 15 ML, 2 ML, 2 MLS, 20 ., 20 ML, 30 ML, 4 ML, 40 ML, 50 ML, 6 ML, 80 ML, 9 ML; BRILLIANT BLUE G, P.F. 2% OPHTHALMIC 11 MLS, 15 MLS (43 DIFFERENT PRODUCTS)
- Product quantity
- 107 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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Location & Firm
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Address
-
1210 SW 33rd Avenue
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1468-2012
- Event ID
- 62416
- Recall initiation date
- May 25, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #'s: 0387683 0393065 0394633 0385938 0387683 0385222 0394375 0389789 0394526 0391261 0399698 0380189 0387389 0384308 0387389 0390830 0370011 0386507 0394133 0397580 0386507 0393521 0374071 0396478 0360399 0377887 0382420 0360399 0382420 0373839 0373839 0367517 0395929 0396303 0398978 0398980 0398983 0398987 0398061 0395908 0366449 0366449 0385953 0395908 0368413 0386587 0387945 0388529 0388631 0390720 0392250 0393056 0395446 0397146 0397459 0399806 0354531 0397967 0399668 0387481 0394553 0396177 0398687 0395424 0388631 0369860 0381370 0388529 0388631 0390143 0392319 0392455 0381370 0393958 0393960 0395294 0396324 0397146 0397149 0389458 0390143 0357319 0369209 0389845 0396123 0360125 0366749 0366749
- More code info
- —