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 tube
    • NDC 52565-090-15
    • b) 30 grams tube
    • NDC 52565-090-30
    • Rx Only
  • Manufactured byTeligent Pharma, Inc., Buena, NJ 08310
Lot codes and dates
  • Batch
    • a) 16878
    • 16912
    • Exp. 5/31/2023
    • b)16878
    • Exp. 5/21/2023
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.

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.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 17, 2024 · Data as of Sep 19, 7:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.