Failed Impurities/Degradation Specifications: Out of specification for impurities.
Failed Impurities/Degradation Specifications: Out of specification for 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 Par Pharmaceutical Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0233-2016 — Par Pharmaceutical Inc. Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets, USP, 12.5 Hello, I own a Par Pharmaceutical Inc. recalls Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct that is covered by recall D-0233-2016 from Par Pharmaceutical 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.