Teligent Pharma is recalling Diflorasone Diacetate Ointment 0.05% tubes due to discontinuation of stability testing, affecting prescription products manufactured in 2022.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling prescription Diflorasone Diacetate Ointment 0.05% tubes because the company stopped its stability testing program. This means the ointment may not be safe for long-term use as it wasn't tested for how it holds up over time.
The recall is due to Teligent Pharma discontinuing its stability study program. This means the ointment wasn't tested to ensure it remains effective and safe over time, so there's a risk it could degrade or become unsafe.
Prescription users of Diflorasone Diacetate Ointment 0.05% tubes with NDC 52565-063-60. Patients who have the ointment from 2022 batches are most at risk.
Check for Diflorasone Diacetate Ointment 0.05% tubes with NDC 52565-063-60. The product was manufactured in batches 15876 (expiring 8/31/2022) or 16205 (expiring 11/30/2022).
Look for the NDC number 52565-063-60 and batch numbers 15876 or 16205 on the ointment tube.
Teligent Pharma discontinued its stability study program, so the ointment wasn't tested to ensure it remains safe and effective over time.
The recall is due to the company stopping stability testing, not an immediate safety risk. The ointment may not be safe for long-term use.
Check the product details to see if it matches the recalled batch numbers. If it does, contact Teligent Pharma for guidance.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0701-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0701-2022 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.
