Teligent Pharma recalls Gentamicin Sulfate Ointment 0.1% tubes due to quality control issues. 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 Gentamicin Sulfate Ointment 0.1% tubes because the company stopped its stability testing program. This means all products within their expiry dates are affected, even though they are safe to use.
The recall is due to Teligent Pharma discontinuing its stability study program, which means the ointment's quality and safety over time could not be confirmed. This affects all products within their expiry dates, but the ointment itself is not harmful when used correctly.
Prescription users of Gentamicin Sulfate Ointment 0.1% tubes with NDC numbers 52565-090-15 or 52565-090-30. Patients who have these products are at risk of receiving unstable medication.
Check for 15g or 30g tubes labeled 'Gentamicin Sulfate Ointment USP 0.1%' with NDC numbers 52565-090-15 or 52565-090-30. These products are prescription-only and were manufactured by Teligent Pharma in Buena, NJ.
Identify the NDC numbers 52565-090-15 or 52565-090-30 on the tube label to confirm if your product is affected.
The ointment is safe to use as long as it is within its expiry date and used correctly. The recall is due to the company discontinuing stability testing, not an immediate safety risk.
Teligent Pharma is recalling all products because they discontinued their stability study program, which means they cannot confirm the ointment's quality over time.
No, you do not need to throw out the ointment. The recall is for quality control reasons, and the ointment is safe to use within its expiry date.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0687-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0687-2022 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.
