Reported Nov 19, 2014 · Terminated
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET…
Fougera Pharmaceuticals Inc.
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: Fougera Pharmaceuticals Inc. · 60 Baylis Rd · Melville, NY · 11747-3838
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | NET WT 15 gram tubes and |
| 2 | NET WT 60 grams tubes |
| 3 | FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 |
| 4 | and NDC 0168-0135-60 (60 g) |
- Lot codes and dates
- a) 15 gram lot numbers
549N550N551N Exp. 1/2015EB1961Exp. 2/2017
- b) 60 gram lot numbers
546N547N548NExp. 1/2015EB0144Exp. 2/2017
- a) 15 gram lot numbers
- Amount recalled
- a) 59,622 Tubes; b) 43,178 Tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
This product could cause temporary or reversible health problems — stop using it.
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