Reported Jun 30, 2021 · Terminated

Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) 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?

  • Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only
  • Manufactured byTeligent Pharma, Inc, Buena, NJ 08310
Lot codes and dates
    • Lot #: 16264
    • Exp Date Nov 2022
Amount recalled
6,240 tubes

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Substance: Foreign particles observed during routine stability testing.

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 Aug 22, 2022 · Data as of Sep 19, 8:08 PM UTC

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