Status
Terminated
Drug Enforcement D-1638-2012
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. 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 15, 2014
Product Information
- Product description
- VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE 400 ML; VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE 0.1 ML 0.2 ML 1 ML 100 ML 150 ML 2 ML 2 MLS 5 ML 50 ML 6 ML 95 ML; VANCOMYCIN HCL, FTV** 1GM INJECTABLE 3 VIAL 4 VIAL; VANCOMYCIN, FORTIFIED 1% (10MG/ML) OPHTHALMIC 10 ML; VANCOMYCIN, FORTIFIED 1.5% (15MG/ML) OPHTHALMIC 15 ML; VANCOMYCIN, FORTIFIED 2% (20MG/ML) OPHTHALMIC 10 ML 15 ML; VANCOMYCIN, FORTIFIED 2.5% (25MG/ML) OPHTHALMIC 10 ML 15 ML; VANCOMYCIN, FORTIFIED 5% (50MG/ML) OPHTHALMIC 10 ML 15 ML 5 ML; VANCOMYCIN, LYOPHILIZED, OPHTHALMIC KIT 1% KIT 1 KIT 1 VIAL 14 KIT 2 KIT 2 KITS 20 KIT 3 KIT 3 KITS 4 KIT 4 KITS 4 VIALS 5 KIT 6 KIT 6 VIAL 9 KIT; VANCOMYCIN, SDPF - (0.2ML SYRINGE, 30G, 1/2") 1% INJECTABLE 0.4 ML 0.6 ML 0.8 ML 1 ML 1.2 ML 1.6 ML (44 DIFFERENT PRODUCTS)
- Product quantity
- 224 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, 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-1638-2012
- Event ID
- 62443
- Recall initiation date
- May 21, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #'s: 0389516 0354047 0389060 0389207 0405939 0402042 0400827 0398001 0398001 0400827 0403914 0369558 0398001 0398001 0382651 0398001 0401260 0401260 0388232 0391059 0392294 0405026 0383386 0396250 0398226 0400971 0409026 0388709 0388791 0393212 0393212 0388791 0392126 0354819 0355230 0363386 0363473 0364197 0368230 0368499 0368573 0368881 0375045 0379341 0379553 0383464 0387849 0389351 0389391 0390955 0392188 0394445 0394681 0394937 0395427 0395954 0396732 0397082 0404021 0404798 0405706 0406017 0408990 0409845 0365234 0393460 0359175 0348859 0351904 0356879 0363386 0364197 0364237 0365742 0366033 0366278 0374625 0375045 0376068 0376172 0380555 0383380 0384293 0387373 0387484 0388897 0392019 0392074 0392237 0394445 0395775 0395954 0397082 0399965 0399990 0403522 0404021 0405332 0407337 0384730 0387512 0389305 0396300 0353129 0355934 0362691 0363386 0363664 0364588 0368573 0368881 0371798 0375690 0376829 0380347 0383380 0387484 0388897 0392019 0392331 0392542 0392778 0394517 0395954 0395388 0355439 0358613 0362691 0366278 0375410 0375512 0375513 0375516 0375517 0375520 0375690 0384293 0387482 0392331 0408623 0376092 0399725 0354424 0392778 0405107 0408480 0408826 0373371 0375355 0375502 0375505 0375508 0375509 0375512 0375513 0375516 0375517 0375520 0392019 0392331 0395775 0398876 0368828 0392019 0358047 0387426 0391713 0393523 0404318 0391713 0391703 0402014 0391703
- More code info
- —