Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
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 Sandoz Incorporated to request your refund or repair — edit it as you like.
Subject: Recall D-1678-2012 — Sandoz Incorporated Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-c Hello, I own a Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz that is covered by recall D-1678-2012 from Sandoz Incorporated. 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.
