Reported Aug 22, 2012 · Terminated
GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE)…
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?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML |
| 2 | GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML |
| 3 | GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER 0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML |
| 4 | GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML |
| 5 | GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML |
| 6 | GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML |
| 7 | GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML |
| 8 | GENTAMICIN IRRIGATION 480MG/LITER SOLUTION 1000 ML, 2000 ML |
| 9 | GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE 100 ML, 100 MLS, 100 VIAL, 12 ML, 14 ML, 150 ML, 200 ML, 25, 40 ML, 50 ML, 50 MLS, 50 VIALS (26 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
120 of 120 codes
040216304011030361246037433904008190401878037676703576270358558038575203874350388683039878203890250389135039453704000510410208038902503882310391057040503103932110393211038879203842880407535037839803783980377517037850303785040380549038168703833190385206039016503901660390930039224103965010396675039783503983120398392039888904025380402842040532004089160378060037850203851650399334039933703993400399345039934804083260405172
- Rx #'s:
- Amount recalled
- 171 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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