Thermo Fisher Scientific voluntarily recalls 4L bottles of 75% isopropyl alcohol hand sanitizer distributed after March 31, 2022, due to FDA guidance requiring cessation of sales under temporary approval.
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Thermo Fisher Scientific is recalling 4-liter bottles of 75% isopropyl alcohol hand sanitizer distributed after March 31, 2022. This recall follows FDA guidance that requires stopping sales of hand sanitizer produced under temporary approval after that date.
The product was distributed after FDA guidance required stopping sales of hand sanitizer under temporary approval. This creates a regulatory risk where the product may not meet safety standards as per FDA requirements.
Users of hand sanitizer produced by Thermo Fisher Scientific after March 31, 2022. Laboratory and medical professionals who use this product are most at risk due to potential regulatory compliance issues.
Check for 4-liter bottles labeled 'HSANI4LI' with isopropyl alcohol content. The product was distributed after March 31, 2022, and has specific lot numbers including 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722, 203723, 203724, 203725, 204852.
Verify the product label for lot numbers listed in the recall notice, including 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722, 203723, 203724, 203725, 204852.
The FDA issued guidance requiring Thermo Fisher Scientific to stop selling hand sanitizer produced under temporary approval after March 31, 2022. This product was distributed after that date.
The recall notice does not specify a remedy or action steps for consumers. Check the product label for lot numbers and contact Thermo Fisher Scientific for further instructions.
The recall notice states that the product was distributed after FDA guidance required stopping sales under temporary approval, so it may not meet safety standards as per FDA requirements.
We’ve drafted a message you can send Thermo Fisher Scientific to request your refund or repair — edit it as you like.
Subject: Recall D-0164-2023 — Thermo Fisher Scientific Thermo Fisher Scientific Hello, I own a Thermo Fisher Scientific that is covered by recall D-0164-2023 from Thermo Fisher Scientific. 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.
