Reported Aug 22, 2012 · Terminated
QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX…
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?
12 of 12 products
| # | Product as published |
|---|---|
| 1 | QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML |
| 2 | QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML |
| 3 | QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML |
| 4 | QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML 2 ML 30 ML 5 ML |
| 5 | QUADMIX 30MG/1MG/20MCG/100MCG/ML INJECTABLE 10 ML 10 MLS 5 ML |
| 6 | QUADMIX 30MG/1MG/40MCG/100MCG/ML INJECTABLE 10 ML |
| 7 | QUADMIX 30MG/2MG/20MCG/100MCG/ML INJECTABLE 10 ML 2 ML 4 ML |
| 8 | QUADMIX 30MG/2MG/40MCG/100MCG/ML INJECTABLE 10 ML 15 ML |
| 9 | QUADMIX 30MG/2MG/60MCG/100MCG/ML INJECTABLE 5 ML |
| 10 | QUADMIX 30MG/3MG/50MCG/100MCG/ML INJECTABLE 10 ML 2.5 ML |
| 11 | QUADMIX 30MG/4MG/60MCG/100MCG/ML INJECTABLE 5 ML |
| 12 | QUADMIX 30MG/6MG/60MCG/100MCG/ML INJECTABLE 5 ML (22 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
85 of 85 codes
039815403614270394539039837903983830398654040148103549010358554036239903645650365677037421403781400387717038782803884100388613038958203896050389831038999503918360392132039279103957610395780039856503991390399236040203904023480402913040465504049560407300040782604078860409193040939203815410381541037420003883330389328038999504002610400734040127504083000369037039950703934320400721037649803985170405296038242203830300387924
- Rx #'s:
- Amount recalled
- 110 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. 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.
Want the full recall guide?
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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