CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
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 Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-1092-2014 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA recalls Teva Ethambutol Hydrochloride Tablets, US Hello, I own a Teva Pharmaceuticals USA recalls Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, that is covered by recall D-1092-2014 from Teva Pharmaceuticals USA. 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.
