Reported Aug 22, 2012 · Terminated
ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS 24 ML 3 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?
- ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 1 ML 10 ML 10 MLS 12 ML 15 ML 18 ML 2 ML 20 ML 20 MLS 24 ML 3 ML 30 ML 5 ML 6 ML 8 ML 9 ML; ULTRA-TEST 200 IN SESAME OIL (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 10 ML 30 ML 8 ML; ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE 10 ML 20 ML (21 DIFFERENT PRODUCTS)
- Lot codes and dates
- Rx #'s:C0389434
1,155 of 1,155 codes
C0389437C0389439C0389440C0389441C0389442C0389444C0389445C0389446C0389447C0389448C0389449C0389450C0389451C0389452C0389453C0389454C0389455C0391550C0397034C0402354C0372981C0377330C0380467C0380957C0381304C0382133C0383978C0384095C0385948C0385973C0385977C0385980C0386103C0387091C0387437C0387546C0387549C0387587C0387588C0387589C0387733C0387734C0387736C0387738C0387753C0388095C0388096C0388097C0388098C0388099C0388100C0388101C0388107C0388208C0388209C0388211C0388212C0388216C0388217C0388247
- Rx #'s:C0389434
- Amount recalled
- 1193 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.
Want the full recall guide?
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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