Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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 Unichem Pharmaceuticals USA Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0010-2018 — Unichem Pharmaceuticals USA Inc. Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablet Hello, I own a Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. that is covered by recall D-0010-2018 from Unichem Pharmaceuticals USA 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.
