Teligent Pharma recalls 0.05% Diflorasone Diacetate Ointment tubes due to foreign particles detected during stability testing. Rx-only product with NDC numbers 52565-063-15 and 52565-063-30.
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Teligent Pharma is recalling 0.05% Diflorasone Diacetate Ointment tubes (15g and 30g) because foreign particles were found during testing. This is a prescription-only product that could pose a risk if the particles enter the skin.
Foreign particles were detected during routine stability testing. While the ointment is prescription-only, these particles could potentially cause minor skin irritation if they come into contact with the skin.
Prescription users of the 0.05% Diflorasone Diacetate Ointment. People with sensitive skin or those using the product for extended periods may be at slightly higher risk.
Check for 15g (NDC 52565-063-15) or 30g (NDC 52565-063-30) tubes labeled 'Diflorasone Diacetate Ointment USP 0.05%'. This product is only available by prescription.
Verify the product's NDC number is 52565-063-15 or 52565-063-30 to confirm it's part of this recall.
The recall is due to foreign particles found during testing, but the product is still safe for use unless the particles cause skin irritation. Consult your doctor if you experience irritation.
Check for 15g (NDC 52565-063-15) or 30g (NDC 52565-063-30) tubes labeled 'Diflorasone Diacetate Ointment USP 0.05%'. This product is prescription-only.
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to stop using the product.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0636-2021 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0636-2021 from Teligent Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
