CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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 Hetero Labs Limited (Unit V) to request your refund or repair — edit it as you like.
Subject: Recall D-1115-2018 — Hetero Labs Limited (Unit V) Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsar Hello, I own a Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber that is covered by recall D-1115-2018 from Hetero Labs Limited (Unit V). 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.
