Reported Mar 30, 2022 · Terminated
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g…
Teligent Pharma, 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: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310
Is this the product you have?
Fluocinonide Gel USP0.05%packaged in a) 15 g tubesNDC 52565-054-15b) 60 g tubesNDC 52565-054-60c) 30 g tubesNDC 52565-054-30Rx OnlyTeligent PharmaIncBuenaNJ 08310
- Lot codes and dates
- Batch
a) 15122Exp. 2/28/202215475Exp. 3/31/2022b) 15119Exp. 2/28/202215122Exp. 2/28/202215380Exp. 3/31/2022c) 15380Exp. 3/31/2022
- Batch
- Amount recalled
- 51,748 tubes
This recall covers 37 products
The agency filed one notice per product. You are reading one of them; the other 36 are below.
24 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
This product could cause temporary or reversible health problems — stop using it.
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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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