Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
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 X-Gen Pharmaceuticals Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0328-2021 — X-Gen Pharmaceuticals Inc. X-Gen Pharmaceuticals Inc. recalls Neomycin Sulfate Tablets, USP 500mg, Hello, I own a X-Gen Pharmaceuticals Inc. recalls Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. that is covered by recall D-0328-2021 from X-Gen Pharmaceuticals 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.