Teligent Pharma recalls 0.05% Clobetasol Propionate Cream due to cGMP deviations in stability testing. All products within expiry are affected as the company discontinues its stability study program.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling all 0.05% Clobetasol Propionate Cream products (15g, 30g, 45g, 60g tubes) because the company discontinued its stability testing program, which could affect product safety. This recall affects prescription-only products sold with specific batch numbers and expiration dates.
The recall is due to cGMP deviations where the manufacturer discontinued its stability study program. This means the product's safety and effectiveness could be compromised over time, though the products are still safe for use within their expiration dates.
Prescription users of Clobetasol Propionate Cream who purchased the affected tube sizes from Teligent Pharma. Those with the specific batch numbers and expiration dates listed are most at risk.
Check for the product name 'Clobetasol Propionate Cream USP 0.05% (Emollient)' in 15g, 30g, 45g, or 60g tubes with NDC numbers 52565-094-15, 52565-094-30, 52565-094-45, or 52565-094-60. Also look for specific batch numbers and expiration dates listed in the recall notice.
Identify the tube size, NDC number, and batch number to confirm if your product is affected.
The product is safe for use within its expiration date, but the recall is due to the manufacturer discontinuing stability testing, which could affect long-term safety.
Teligent Pharma is recalling all products because they discontinued their stability study program, which is a cGMP deviation.
The recall does not specify a return process, so you do not need to return the product. However, you should check if your product is 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-0671-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0671-2022 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.
