Teligent Pharma is recalling Lidocaine Ointment 5% tubes (Rx only) produced between February 2024 due to quality control deviations. All recalled products are being discontinued after the stability study program was halted.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Teligent Pharma is recalling Lidocaine Ointment 5% tubes (35.44g) that were manufactured with batch numbers 16389 and 16452. The recall is due to the company discontinuing its stability testing program, which means these products may not meet quality standards.
The recall is due to Teligent Pharma discontinuing its stability study program, which means the products may not meet quality standards. This could affect the ointment's effectiveness or safety, though no specific harm has been reported.
Prescription users of Lidocaine Ointment 5% tubes with batch numbers 16389 or 16452, expiring February 29, 2024. Patients who have this specific product are most at risk.
Check for batch numbers 16389 or 16452 on the tube label. The ointment expires February 29, 2024, and is sold as a prescription-only product.
Verify the batch number and expiration date on the tube label to confirm if it is part of the recall.
Teligent Pharma is recalling these products because they discontinued their stability study program, which means the products may not meet quality standards.
The recall is due to quality control issues, but no specific injuries have been reported. The risk is low as the ointment is prescription-only and the issue relates to quality standards, not immediate safety hazards.
Check for batch numbers 16389 or 16452 on the tube label, and the expiration date is February 29, 2024.
We’ve drafted a message you can send Teligent Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0694-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0694-2022 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.
