Teligent Pharma is recalling Nystatin and Triamcinolone Acetonide Ointment products due to cGMP deviations in stability testing. All affected batches are being discontinued as the company halts 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 Nystatin and Triamcinolone Acetonide Ointment tubes because the company stopped its stability testing program. This recall affects all products within their expiration dates, but there is no immediate risk of harm to users.
The recall is due to the company discontinuing its stability testing program, which means the products may not meet quality standards. However, the hazard does not involve immediate risks like injury or illness in normal use.
Prescription ointment users who have the specific tube sizes (15g, 30g, or 60g) with the listed NDC numbers and expiration dates. Patients using these products are most at risk if they have the recalled batches.
Check for ointment tubes labeled with NDC numbers 52565-042-15, 52565-042-30, or 52565-042-60. Products with the listed expiration dates (e.g., 2/28/2022 to 3/31/2023) are affected.
Identify the NDC number and expiration date on the ointment tube to confirm if it is in the recalled list.
The recall is due to quality control issues, but there is no indication of immediate harm to users. The company is discontinuing stability testing, so products may not meet quality standards.
The official notice does not specify a remedy, so you should check with your healthcare provider or the manufacturer for guidance.
Yes, the affected batches include specific expiration dates and NDC numbers listed 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-0695-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0695-2022 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.
