Reported Mar 30, 2022 · Terminated
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx…
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?
Gentamicin Sulfate Cream USP0.1%packaged in a) 15 g tubesNDC 52565-085-15b) 30 g tubesNDC 52565-085-30Rx Only
- Manufactured byTeligent Pharma, Inc., Buena, NJ 08310
- Lot codes and dates
- Batch
a) 153421534316686Exp. 3/31/2023b) 1525915260Exp. 3/31/202215282Exp. 4/30/202215283Exp. 5/31/2022157251574515764Exp. 6/30/202216066Exp. 10/31/2022
- Batch
- Amount recalled
- 355,672 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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