Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
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 Actavis Inc to request your refund or repair — edit it as you like.
Subject: Recall D-1471-2016 — Actavis Inc Actavis Inc recalls Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Hello, I own a Actavis Inc recalls Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis that is covered by recall D-1471-2016 from Actavis 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.
