Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Boehringer Ingelheim Roxane Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1427-2014 — Boehringer Ingelheim Roxane Inc Boehringer Ingelheim Roxane Inc recalls Calcitriol Oral Solution 1 Hello, I own a Boehringer Ingelheim Roxane Inc recalls Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC that is covered by recall D-1427-2014 from Boehringer Ingelheim Roxane Inc. 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.
