Reported Aug 22, 2012 · Terminated
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
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?
- TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS)
- Lot codes and dates
- Rx #'s:
61 of 61 codes
T0372867T0387431T0388104T0389467T0389651T0389841T0391671T0394240T0395182T0395583T0396607T0397069T0397176T0398192T0399822T0399900T0400079T0400081T0400293T0400444T0400658T0400794T0400806T0400871T0401635T0401644T0401957T0402166T0402388T0402390T0402553T0402656T0402943T0403559T0405372T0405460T0406116T0406555T0406565T0406984T0407064T0407383T0407394T0407440T0407793T0408122T0408306T0408399T0408744T0409050T0409093T0409107T0409169T0409178T0396714T0394672T0395926T0394672T0394672T0398564
- Rx #'s:
- Amount recalled
- 64 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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