Akorn recalls 0.005% Calcipot: Scalp Solution 60mL bottles due to CGMP deviations after firm went out of business. No remedy provided in official notice.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn is recalling 60mL Calcipotriene Topical Solution (Scalp Solution) bottles because the manufacturer went out of business and can no longer conduct stability tests. This means the product's safety and effectiveness cannot be guaranteed.
The manufacturer went out of business and can no longer perform stability studies, which are necessary to ensure the product remains safe and effective over time. Without these studies, the product's quality cannot be verified.
Prescription users of the 0.005% Calcipotriene Scalp Solution 60mL bottles. Those who have the product are at risk due to the manufacturer's inability to maintain quality standards.
Check for 60mL bottles labeled 'Calcipotriene Topical Solution, 0.005% (Scalp Solution)' with prescription status. All National Drug Codes (NDCs) and lots are affected.
Identify the product by checking the label for 60mL bottles of Calcipotriene Topical Solution, 0.005% (Scalp Solution).
The official notice does not provide a remedy.
The manufacturer went out of business and can no longer continue stability studies.
Check for 60mL bottles labeled 'Calcipotriene Topical Solution, 0.005% (Scalp Solution)' with prescription status.
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0789-2023 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0789-2023 from Akorn. 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.
