Akorn recalls Lidocaine 2:5% and Prilocaine 2:5% cream tubes due to CGMP deviations after manufacturer went out of business.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling Lidocaine 2.5% and Prilocaine 2.5% cream tubes because the manufacturer went out of business and could no longer perform stability tests. This means the product may not be safe for use as intended.
The manufacturer went out of business and could no longer conduct stability studies. This means the product's safety and effectiveness could be compromised over time.
People with prescriptions for this cream are affected. Those who have the product and are using it for medical purposes are most at risk.
Check for Lidocaine 2.5% and Prilocaine 2.5% cream tubes labeled as Rx Only. All products manufactured by HI-TECH PHARMACAL CO., INC. in Amityville, NY are affected.
Look for the product name and manufacturer on the tube label to confirm it matches the recalled items.
The manufacturer went out of business and could no longer continue stability studies, which means the product's safety and effectiveness may be compromised.
The recall record does not specify a remedy.
Check for Lidocaine 2.5% and Prilocaine 2.5% cream tubes labeled as Rx Only, manufactured by HI-TECH PHARMACAL CO., INC. in Amityville, NY.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0821-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0821-2023 from Akorn. 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.
