Red Mountain Compounding Pharmacy recalls hydroxyprogesterone caproate 250mg/ml injection (Rx only) due to FDA sterility concerns. All lots within expiry date are affected.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling hydroxyprogesterone caproate 25:00mg/ml injection (Rx only) because FDA inspections found sterility assurance issues. This could lead to infections if the medication is used.
FDA inspections identified sterility assurance concerns for this medication. If the product is not sterile, it could cause infections when injected into the body.
People with prescriptions for hydroxyprogesterone caproate injection are affected. Those using the medication for medical purposes are at risk of infection.
Check for the product name 'hydroxyprogesterone caproate 250mg/ml injection' with the manufacturer 'Red Mountain Compounding Pharmacy'. All lots within the expiry date are affected.
Identify the product name and manufacturer to confirm if it is recalled.
The FDA has raised sterility assurance concerns, so the product may not be safe to use. Consult your healthcare provider.
The recall does not specify a remedy, so contact the manufacturer for guidance.
The recall affects all lots within the expiry date, so check the product label for the lot number.
We’ve drafted a message you can send Red Mountain Compounding Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0039-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0039-2022 from Red Mountain Compounding Pharmacy. 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.
