Teligent Pharma recalls Desonide Ointment 0.05% tubes due to cGMP deviations. All products within expiry are affected as the company discontinues stability testing.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Desonide Ointment 0.05% tubes (15g and 60g) because the company stopped its stability testing program. This means all products within their expiry dates are being recalled, even though they haven't caused any injuries.
The recall is due to the company discontinuing its stability testing program, which means the product's quality and safety over time could not be confirmed. This is a cGMP (current Good Manufacturing Practice) deviation, but it does not indicate immediate harm to users.
Prescription users of Desonide Ointment 0.05% tubes from Teligent Pharma. People with skin conditions requiring this medication are most at risk.
Check for 15g or 60g tubes labeled with NDC 52565-038-15 or 52565-038-60. The product is prescription-only and has specific batch numbers and expiration dates listed in the recall notice.
Look for the NDC codes 52565-038-15 or 52565-038-60 on the tube label.
The recall is due to the company discontinuing stability testing, not immediate safety risks. Users should check if they have the recalled product and follow the recall instructions.
Teligent Pharma stopped its stability testing program, which is a cGMP deviation. This means the product's long-term safety and quality could not be confirmed.
The recall does not require immediate discontinuation. Check if you have the recalled product and follow the instructions to confirm if it's affected.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0675-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0675-2022 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.
