Reported Aug 22, 2012 · Terminated
EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/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?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML |
| 2 | EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 2400 ML, 500 ML |
| 3 | EDTA CALCIUM DISODIUM SOLUTION 2% OPHTHALMIC 5 ML |
| 4 | EDTA DISODIUM (P.F.) 150MG/ML INJECTABLE 1000 ML, 1200 ML, 1500 ML, 400 ML, 500 ML, 900 ML |
| 5 | EDTA DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 1000 ML, 2000 ML, 8000 ML |
| 6 | EDTA DISODIUM (PRESERVATIVE FREE) 3%/ML INJECTABLE 12 ML |
| 7 | EDTA DISODIUM IN NATURAL TEARS 1.5% OPHTHALMIC 5 ML |
| 8 | EDTA DISODIUM IN NATURAL TEARS 3% OPHTHALMIC 15 ML, 30 ML (18 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
03883160388963038912603896350391611040621503952520392864039597803907480390748039074803916300391630039074804003190388489038848903893200390209040399703822110381428
- Rx #'s:
- Amount recalled
- 28 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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