Teligent Pharma recalls Clobetasol Propionate Gel 0.05% due to discontinued stability testing. All products within expiry are affected. No remedy specified in recall notice.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Clobetasol Propionate Gel 0.05% products because the company has stopped its stability testing program. This recall affects all gel tubes sold with specific NDC numbers and expiration dates. The issue does not pose an immediate safety risk but requires product removal from use.
The recall is due to Teligent Pharma discontinuing its stability study program, which means the product's long-term safety and effectiveness cannot be confirmed. This does not indicate an immediate hazard like injury or illness but requires the product to be removed from use until a stable alternative is available.
Prescription users of Clobetasol Propionate Gel 0.05% in the U.S. who have the specific tube sizes and NDC numbers listed. Patients with skin conditions requiring topical corticosteroids are most at risk if they continue using the product without the stability study.
Check for 15g or 30g tubes labeled with NDC 52565-082-15 or 52565-082-30, or 60g tubes with NDC 52565-082-60. Products were sold with specific batch numbers and expiration dates listed in the recall notice.
Identify the tube size and NDC number to confirm if your product is recalled.
The recall is due to discontinued stability testing, not an immediate safety hazard. The product is safe for use but should be removed from use until a stable alternative is available.
The recall notice does not specify a return process or remedy, so no action is required beyond checking if the product is recalled.
Recalled products have specific expiration dates listed in the recall notice, including 2/28/2022 through 4/30/2023.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0674-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0674-2022 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.
