Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% tubes (30g) because the manufacturer discontinued its stability testing program, affecting products from specific batches.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% (30g tubes) due to the company discontinuing its stability testing program. This recall affects prescription-only products with specific batch numbers and expiration dates. The issue means the cream's long-term safety and effectiveness cannot be confirmed without ongoing testing.
The manufacturer discontinued its stability testing program, meaning the product's long-term safety and effectiveness cannot be confirmed. This could lead to reduced efficacy or potential safety issues over time, but the recall does not indicate immediate harm.
Prescription patients who have the specific batch numbers of Gentamicin Sulfate Cream USP 0.1% (30g tubes) from Teligent Pharma. Patients using the product for infections or wounds are most at risk if the cream's stability is compromised.
Check for the product name 'Gentamicin Sulfate Cream USP 0.1%', 30g tubes, prescription-only status. Look for batch numbers 15725 (expiring 6/30/2022) or 16113 (expiring 10/31/2022) on the tube.
Identify the batch number and expiration date on the tube to confirm if it's affected.
The recall indicates the manufacturer discontinued stability testing, so long-term safety and effectiveness cannot be confirmed. However, the product may still be safe for short-term use if stored properly.
Check for batch numbers 15725 (expiring 6/30/2022) or 16113 (expiring 10/31/2022) on the tube of Gentamicin Sulfate Cream USP 0.1% (30g).
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to continue using the product.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0702-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0702-2022 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.
