Teligent Pharma is recalling Lidocaine Ointment 5% tubes (NDC 50383-341-35) manufactured for Hi-Tech Pharmacal Co. due to discontinued stability testing. All products within expiry are affected.
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 for Hi-Tech Pharmacal Co. The recall is because the manufacturer discontinued its stability testing program, which means the product's safety over time cannot be confirmed.
The recall occurs because the manufacturer discontinued its stability testing program. This means the product's safety and effectiveness over time cannot be confirmed, though the ointment itself is not immediately hazardous.
Prescription holders of the Lidocaine Ointment 5% tube (NDC 50383-341-35) manufactured for Hi-Tech Pharmacal Co. in Amityville, NY. Patients using this ointment for medical purposes are most at risk.
Check for the Lidocaine Ointment USP 5% tube (35.44g) with NDC 50383-341-35. It was manufactured for Hi-Tech Pharmacal Co. in Amityville, NY and has batch number 16695, expiring April 30, 2024.
Verify the product's NDC number (50383-341-35) and batch number (16695) to confirm it is affected.
The manufacturer discontinued its stability testing program, so the product's safety over time cannot be confirmed.
No immediate danger is reported; the recall is due to the lack of stability testing, not a risk of injury or harm.
Check for the Lidocaine Ointment USP 5% tube (35.44g) with NDC 50383-341-35, batch 16695, expiring April 30, 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-0705-2022 — Teligent Pharma Teligent Pharma Hello, I own a Teligent Pharma that is covered by recall D-0705-2022 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.
