BRP Pharmaceuticals recalls Butalbital, APAP, Caf 50/325/40 Tablets with missing CIII classification label. This controlled substance requires proper labeling for legal use.
Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label
BRP Pharmaceuticals is recalling certain Butalbital tablets due to missing controlled substance classification (CIII) on the label. This affects legal compliance and potential misuse risks for prescription medications.
The missing CIII classification label means the medication is not properly identified as a controlled substance. This could lead to improper handling or legal issues, but does not pose a direct physical safety risk.
Prescription holders of the recalled Butalbital tablets. Individuals with the specific lot numbers and expiration dates listed are most at risk.
Check for 12-count, 60-count, or 90-count bottles with NDC numbers 63629-8392-09, 63629-8392-03, or 63629-8392-04. Look for specific lot numbers and expiration dates listed in the recall.
Verify if the label shows the controlled substance classification "CIII" for Butalbital tablets.
The recall is for missing controlled substance classification (CIII) on the label, which is required for legal prescription use.
No, but you should check the label for the CIII classification to ensure proper legal use.
The official notice does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send BRP Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0256-2022 — BRP Pharmaceuticals BRP Pharmaceuticals Hello, I own a BRP Pharmaceuticals that is covered by recall D-0256-2022 from BRP Pharmaceuticals. 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.
