Reported Aug 22, 2012 · Terminated
KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML; KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE 10 ML 24 ML 500 ML |
| 2 | KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE 48 ML |
| 3 | KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE 50 ML 75 ML |
| 4 | KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE 10 ML (7 DIFFERENT PRODUCTS) |
- Lot codes and dates
- Rx #'s:
040722504078520405175040819304032430404737039257303925750392577039257504019510404831
- Rx #'s:
- Amount recalled
- 14 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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