ULTRAtab Laboratories recalls Migrenol Caplets (500mg acetaminophen, 65mg caffeine) due to CGMP deviations in bulk containers. Affected units include specific NDC and product codes.
CGMP Deviations
ULTRAtab Laboratories is recalling Migren:ol Caplets (500mg acetaminophen, 65mg caffeine) in bulk containers due to CGMP deviations. This means the product may not meet quality standards, though the recall does not specify immediate safety risks.
CGMP deviations refer to failures in manufacturing quality control processes. This means the product may not meet the required quality standards for safety and effectiveness, though the specific risks are not detailed in this recall.
People who purchased Migrenol Caplets in bulk containers with NDC 62959-565-00 or product code M565L from ULTRAtab Laboratories in Highland, NY are affected. Those using the product for pain relief may be at risk if the product does not meet quality standards.
Check for the product code M565L or NDC 62959-565-00 on the bulk container. The product was manufactured in Highland, NY under ULTRAtab Laboratories.
Look for the product code M565L or NDC 62959-565-00 on the bulk container.
The recall states there were CGMP deviations, which means the product may not meet quality standards, but specific safety risks are not detailed in this notice.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected product.
Check for the product code M565L or NDC 62959-565-00 on the bulk container, which was manufactured in Highland, NY by ULTRAtab Laboratories.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0547-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0547-2022 from ULTRAtab Laboratories. 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.
