Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature 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 Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1417-2012 — Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals Vintage Pharmaceuticals LLC DBA Qualites Hello, I own a Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals recalls HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST that is covered by recall D-1417-2012 from Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals. 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.
