Reported Oct 31, 2018 · Terminated
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc.…
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 SolutionUSP 0.01%60ml Bottle
- Manufactured forLupin Pharmaceutical, Inc. Baltimore
- MD 21202 Manufactured byNovel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
- Lot codes and dates
Lot# M16666EXP 12/2018
- Amount recalled
- 2712 60-ml bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
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.
Free recall alerts
Get alerted about new Lupin Somerset recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.