Reported Aug 22, 2012 · Terminated
MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML; MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40…
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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE 100 ML |
| 2 | MIDAZOLAM 1MG/ML INJECTABLE 100 ML 108 ML 1250 ML 20 ML 292 ML 300 ML 40 ML 500 ML 90 ML |
| 3 | MIDAZOLAM 5MG/ML INJECTABLE 140 ML 150 ML 200 ML |
| 4 | MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE 100 MLS (13 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:C0392008
C0401692C0401728C0392845C0398970C0401801C0402374C0392845C0396878C0391291C0402620C0403051C0396889C0401679C0402560C0394688
- Rx #'s:C0392008
- Amount recalled
- 16 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.
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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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