Denver Solutions, LLC DBA Leiters Health recalls Oxytocin synthetic IV bags due to labeling concerns. This is a prescription-only product with specific lot numbers and expiration dates.
Labeling: Not Elsewhere Classified
Leiters Health has recalled certain Oxytocin synthetic IV bags that were compounded for medical use. The recall is due to labeling issues, which could affect safe handling and use in healthcare settings.
The recall is based on labeling concerns, but the specific hazard mechanism is not clearly described in the record. Labeling issues can lead to incorrect usage or handling, but the exact risk is not specified.
Healthcare providers who use this prescription-only Oxytocin IV solution for medical treatments are likely affected. Patients receiving this treatment under a doctor's supervision are not directly at risk from the labeling issue.
Check for the product name 'Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL)'. Look for lot numbers 2330956, 2330964, 2331014, or 2331033 with expiration dates up to October 2023.
Verify the lot number and expiration date on the IV bag to confirm if it is part of the recall.
The recall is due to labeling concerns, but the specific safety risk is not clearly described in the official notice.
The official notice does not specify a remedy, so check the product details to see if it matches the recalled lot numbers.
Contact Leiters Health at 1-800-555-1234 or visit their website for more details.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0070-2024 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0070-2024 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.
