CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
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 Lannett Company Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0083-2019 — Lannett Company Inc. Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hyd Hello, I own a Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by that is covered by recall D-0083-2019 from Lannett Company 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.
