Leiters Health recalls phenylephrine HCl IV bags due to CGMP deviations. Affected units have specific lot and expiration dates. Contact for remedy details.
CGMP DEVIATIONS
Leiters Health is recalling phenylephrine HCl IV bags that were manufactured with CGMP deviations. This means the product may not meet safety standards and could pose risks during medical use.
CGMP deviations indicate the product was not made according to strict quality control standards. This could lead to inconsistent dosing or safety issues during medical procedures.
Healthcare facilities using the recalled IV bags are most at risk. Patients receiving treatment with these bags could be affected if the product is used incorrectly.
Check for the product name 'Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag' with lot number 2231017 and expiration date 3/12/2023.
Look for the lot number 2231017 and expiration date 3/12/2023 on the IV bag.
The recall indicates CGMP deviations, meaning the product may not meet safety standards. The manufacturer has not provided a remedy, so it is not safe to use.
Check for the lot number 2231017 and expiration date 3/12/2023 on the IV bag.
The manufacturer has not provided a remedy, so contact Leiters Health for further instructions.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0444-2023 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0444-2023 from Leiters Health. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
