FDA Drug recall D-1466-2012
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML by Franck S Lab D B A Franck S Compounding Lab, citing 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 re….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1466-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-25 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Franck S Lab D B A Franck S Compounding Lab |
| Distribution | US |
Product
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX 26MG/2MG/ML INJECTABLE 20 ML; BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX 30MG / 1.5MG INJECTABLE 5 ML; BIMIX 30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS, 12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM 9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG INJECTABLE 10 ML, 10 MLS; BIMIX, SDSM 30MG / 1.5MG INJECTABLE 10 ML, 10 MLS, 5 ML, 5 MLS; BIMIX, SDSM 30MG / 1MG INJECTABLE 10 ML, 5 ML (58 DIFFERENT PRODUCTS)
Reason
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.
Identifiers
| code_info | Rx #'s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 03…Rx #'s: 0384355, 0389246, 0392332, 0399800, 0407377, 0385460, 0389158, 0402762, 0385460, 0359057, 0385462, 0396242, 0385462, 0391321, 0372399, 0400437, 388360, 0350745, 0354900, 0357950, 0365803, 0391686, 0393285, 0393620, 0395404, 0399228, 0399302, 0401675, 0401844, 0403731, 0406162, 0408427, 0409073, 0399228, 0371562, 0376422, 0396380, 0405576, 0405582, 0405586, 0384289, 0366702, 0360431, 0408278, 0390548, 0396007, 0401479, 0352078, 0352368, 0354526, 0354595, 0357480, 0358685, 0359207, 0363768, 0364549, 0368498, 0369212 0373766 0374428 0375279 0375571 0375873 0377397 0380000 0380005 0381659 0382914 0384657 0386665 0387419 0387519 0387699 0388026 0388292 0388330 0388766 0389900 0390082 0390315 0391607 0392449 0392525 0392848 0393087 0393381 0393499 0393828 0393904 0394395 0394985 0395878 0395912 0396010 0396019 0396120 0396163 0396207 0396267 0396366 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1466-2012%22
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