Teligent Pharma recalls 0.05% Clobetasol Propionate Lotion due to cGMP deviations. All products within expiry are being recalled 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 0.05% Clobetasol Propionate Lotion in 2 fl. oz. and 4 fl. oz. bottles because the company stopped its stability testing program. This recall affects prescription-only products with specific batch numbers and expiration dates.
The recall is due to the manufacturer discontinuing its stability study program, which means the product's quality and safety cannot be verified over time. This is a cGMP (current Good Manufacturing Practice) deviation, but it does not pose an immediate risk of injury or harm to users.
Prescription users of the recalled lotion, particularly those with specific batch numbers and expiration dates. Patients using the product for skin conditions are most at risk due to the recall.
Check for 2 fl. oz. (59 mL) or 4 fl. oz. (118 mL) bottles labeled with NDC 52565-055-02 or 52565-055-04. The product is prescription-only and has specific batch numbers and expiration dates listed in the recall notice.
Identify the product by checking the bottle size, NDC code, and expiration date.
The recall is due to the manufacturer discontinuing stability testing, but the product is not expected to cause immediate harm. Users should check if they have the recalled batch numbers.
Teligent Pharma is recalling the product because they stopped their stability study program, which is a cGMP deviation.
No immediate action is required beyond checking if you have the recalled batch numbers. The recall does not pose a risk of injury or harm.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0672-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0672-2022 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.
