Reported Mar 30, 2022 · Terminated

Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes,…

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?

3 of 3 products

Products covered by this recall
#Product as published
115 grams tubes, NDC 52565-042-15
230 grams tubes, NDC 52565-042-30
360 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Lot codes and dates
  • Batch
    • a) 15125
    • Exp. 2/28/2022
    • 15385
    • Exp. 3/31/2022
    • 15613
    • Exp. 5/31/2022
    • 16027
    • Exp. 9/30/2022
    • 16204
    • Exp. 11/30/2022
    • 16376
    • Exp. 1/31/2023
    • 16707
    • Exp. 3/31/2023
    • b) 15385
    • Exp. 3/31/2022
    • 15752
    • Exp. 6/30/2022
    • 15346
    • Exp. 9/30/2022
    • 16188
    • Exp. 11/30/2022
    • 16567
    • Exp. 2/28/2023
    • 16730
    • Exp. 4/30/2023
    • c)15752
    • Exp. 6/30/2022
    • 16188
    • Exp. 11/30/2022
Amount recalled
217,184 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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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, 8:00 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.