Pallimed Solutions recalls hydroxyprogesterone capsules due to sterility concerns from FDA quality control issues. Affected lots may cause infections if used.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Pallimed Solutions is recalling hydroxyprogesterone capsules because their manufacturing process failed to ensure sterility, which could lead to infections if the product is used. This is a serious safety issue that requires immediate attention.
The capsules were compounded by Pallimed Solutions Pharmacy in Woburn, MA, and the FDA found that their quality control procedures did not adequately ensure sterility. This means the product could contain harmful bacteria or other contaminants that could cause infections when used.
Women using hydroxyprogesterone capsules for medical purposes, especially those with compromised immune systems or pregnant individuals. Healthcare providers who dispensed the product are also at risk.
Check for the product name 'Hydroxyprogesterone CAPR.(G.S.)' compounded by Pallimed Solutions Pharmacy in Wob:urn, MA. All lots within the expiration date are affected.
Immediately stop using the recalled hydroxyprogesterone capsules as they may contain contaminants that could cause infections.
The FDA found that Pallimed Solutions' quality control procedures did not ensure sterility, which could lead to infections if the product is used.
Look for the product name 'Hydroxyprogesterone CAPR.(G.S.)' compounded by Pallimed Solutions Pharmacy in Woburn, MA. All lots within the expiration date are affected.
Immediately stop using the product and contact your healthcare provider for guidance.
We’ve drafted a message you can send Pallimed Solutions to request your refund or repair — edit it as you like.
Subject: Recall D-870-2013 — Pallimed Solutions Pallimed Solutions Hello, I own a Pallimed Solutions that is covered by recall D-870-2013 from Pallimed Solutions. 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.
