Failed Impurity/Degradation Specification; 12-month stability time point
Failed Impurity/Degradation Specification; 12-month stability time point
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 Novel Laboratories, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1484-2014 — Novel Laboratories, Inc. Novel Laboratories, Inc. recalls Famotidine for Oral Suspension, USP 40 mg Hello, I own a Novel Laboratories, Inc. recalls Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured that is covered by recall D-1484-2014 from Novel Laboratories, 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.
