CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
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 VistaPharm, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0460-2017 — VistaPharm, Inc. VistaPharm, Inc. recalls Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose Hello, I own a VistaPharm, Inc. recalls Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, that is covered by recall D-0460-2017 from VistaPharm, 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.
