Reported Jan 30, 2019 · Terminated
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for
Lupin Somerset
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: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 |
| 2 | Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873 |
| 3 | NDC 43386-069-60. |
- Lot codes and dates
Lot #: S700214Exp Apr-19S700447Exp Jun-19S700787Exp Oct-19S701057Exp Nov-19S800107Exp Feb-20S800266Exp Mar-20S800524Exp May-20S800791Exp Jul-20
- Amount recalled
- 24,180 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.
This product could cause temporary or reversible health problems — stop using it.
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