Reported Aug 22, 2012 · Terminated
TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML; TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12…
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?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC 10 ML |
| 2 | TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC 0.5 ML 1.5 ML 10 ML 12 ML 2 ML 2.5 ML 3 ML 4 ML 4.5 ML 5 ML 6 ML 7.5 ML 8 ML |
| 3 | TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC 10 ML 2.5 ML |
| 4 | TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC 1 ML 1.5 ML 10 ML 12 ML 2 ML 25 ML 4 ML 5 ML 50 ML |
| 5 | TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC 10 ML |
| 6 | TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 3 ML 4.5 ML 9 ML |
| 7 | TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC 12 ML (30 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
039644703919040396678039325104003350402500035247403682410387963039494204020890394942040033503524740368241039325103950430368241039325104039360409994039190403496600368241038816303906140391904040199404023320402500039398503682410403168040222704030320395193039667903974540396679038748003875140397147040188104051050409255039714704036300397147040184603876470390992039714704037420402848040284804028480399288
- Rx #'s:
- Amount recalled
- 102 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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