CLASS II Drug recall · Reported 30 Jun 2021 · FDA Enforcement Report
Diflorasone Diacetate Ointment recalled by Teligent Pharma
Teligent Pharma is recalling Diflorasone Diacetate Ointment USP, 0.05%, distributed nationwide in the US. The recall was initiated on 14 May 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0636-2021
- FDA event ID
- 87950
- Recalling firm
- Teligent Pharma, Buena, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 May 2021
- FDA classified
- 23 Jun 2021
- Reported
- 30 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 May 2021 | Recall initiated by company | |
| 23 Jun 2021 | Classified by FDA | +40 days |
| 30 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Product as listed by the FDA
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 by: Teligent Pharma, Inc, Buena, NJ 08310.
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Which lots are affected?
Lot #: 16264, Exp Date Nov 2022
Where was it sold?
Nationwide in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Gentamicin Sulfate Cream recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
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| Drug | CLASS II | Fluocinonide Gel recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
Other Diflorasone Diacetate recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diflorasone Diacetate Ointment, USP, 0.05% tube recalledDiflorasone Diacetate | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diflorasone Diacetate Ointment recalled by Teligent Pharma | Teligent Pharma | Potency & Assay | Nationwide |