Reported Aug 22, 2012 · Terminated
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML;…
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138
Is this the product you have?
24 of 24 products
| # | Product as published |
|---|---|
| 1 | BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML |
| 2 | BIMIX 30MG / 5MG INJECTABLE 10 ML |
| 3 | BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML |
| 4 | BIMIX 15MG / 1MG INJECTABLE 10 ML |
| 5 | BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML |
| 6 | BIMIX 18MG / 1MG INJECTABLE 5 ML |
| 7 | BIMIX 20MG / 0.75MG INJECTABLE 5 ML |
| 8 | BIMIX 26MG/1MG/ML INJECTABLE 10 ML |
| 9 | BIMIX 26MG/2MG/ML INJECTABLE 20 ML |
| 10 | BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML |
| 11 | BIMIX 30MG / 1.5MG INJECTABLE 5 ML |
| 12 | 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 |
| 13 | BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML |
| 14 | BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML |
| 15 | BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML |
| 16 | BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML |
| 17 | BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML |
| 18 | BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML |
| 19 | BIMIX 40MG/3MG INJECTABLE 3 ML |
| 20 | BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML |
- Lot codes and dates
- 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,
342 of 342 codes
036921203737660374428037527903755710375873037739703800000380005038165903829140384657038666503874190387519038769903880260388292038833003887660389900039008203903150391607039244903925250392848039308703933810393499039382803939040394395039498503958780395912039601003960190396120039616303962070396267039636603969060397063039752303975270397728039829103988620399237039925103996440399898040100104013800401414040148004018580401991
- 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,
- Amount recalled
- 448 units
This recall covers 198 products
The agency filed one notice per product. You are reading one of them; the other 197 are below.
185 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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