Reported Mar 30, 2022 · Terminated
Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC…
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 Ointment USP 0.1%packaged as a) 15 grams tubeNDC 52565-090-15b) 30 grams tubeNDC 52565-090-30Rx Only
- Manufactured byTeligent Pharma, Inc., Buena, NJ 08310
- Lot codes and dates
- Batch
a) 1687816912Exp. 5/31/2023b)16878Exp. 5/21/2023
- Batch
- Amount recalled
- 43,956 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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