Leiters Health recalls specific phenylephrine IV bags (NDC 71449-148-94) due to CGMP deviations. These are prescription-only IV solutions for medical use. Consumers should contact the manufacturer for details.
CGMP DEVIATIONS
Leiters Health has recalled certain phenylephrine HCl 20 mg IV bags that were manufactured with CGMP deviations. This recall affects prescription-only IV solutions used in medical settings, and the issue requires immediate attention from healthcare providers.
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. These deviations may result in incorrect concentrations or impurities in the IV solution, potentially causing harm to patients during medical procedures.
Healthcare providers who use these specific phenylephrine IV bags for medical treatments are affected. Patients receiving these bags as part of their treatment are at risk if the bags are used without proper quality control.
Check for the NDC number 71449-148-94 on the IV bag label. The product was manufactured with specific lot numbers and expiration dates listed in the recall notice.
Reach out to Leiters Health at 13796 Compark Blvd, Englewood, CO 80112 for specific details about the recalled product.
The recall indicates manufacturing deviations, so these products are not safe for use. Healthcare providers should not use them until the manufacturer provides further instructions.
Contact Leiters Health directly for guidance on how to handle the recalled product. Do not use the product until you receive instructions.
Yes, check for lot numbers 2231026, 2231051, 2231156, 2231163, 223130, and 2231308 as listed in the recall notice.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0445-2023 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0445-2023 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.
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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.
