Teligent Pharma recalls 0.05% Halobetasol Propionate Ointment tubes 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 0.05% Halobetasol Propionate Ointment tubes (15g and 50g) because the company stopped its stability testing program. This means all products within their expiration dates are being recalled, but there's no specific action required for consumers.
The recall is due to Teligent Pharma discontinuing its stability testing program, which means the product's quality and safety over time could not be verified. This is a manufacturing quality issue, not a direct hazard like injury or fire.
People who own or use the recalled ointment tubes (15g and 50g) manufactured by Teligent Pharma. Those most at risk are individuals using the product for medical purposes.
Check for 15g or 50g tubes labeled with NDC 52565-073-15 or 52565-073-51. The product is prescription-only and has specific batch numbers and expiration dates listed in the recall notice.
Identify the product by checking the tube size (15g or 50g), NDC code, and expiration date as listed in the recall notice.
The recall does not require stopping use; it's a quality control issue with the stability testing program, not a direct safety hazard.
The product is safe for use as intended, but the recall means the manufacturer has stopped testing its long-term stability, so it's being recalled for quality assurance.
Check the tube size (15g or 50g), NDC code (52565-073-15 or 52565-073-51), and expiration date against the list provided in the recall notice.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0689-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0689-2022 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.
