ULTRAtab Laboratories recalls acetaminophen/phenylephrine tablets due to manufacturing quality issues. Affected lots include 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, 19J051. No specific remedy provided in recall notice.
CGMP Deviations
ULTRAtab Laboratories is recalling acetaminophen/phenylephrine tablets that were manufactured with CGMP deviations. This means the product may not meet safety standards, though no specific harm has been reported.
CGMP deviations refer to failures in the manufacturing process that could affect product safety and quality. This means the tablets might not be as safe or effective as they should be, though the exact risk is not specified in the recall.
People who purchased the bulk container of APAP 500mg Phenyl HCl tablets with the listed lot numbers from ULTRAtab Laboratories in Highland, NY. Those using the product for pain or cold relief are most at risk.
Check the product label for the NDC code 62959-140-00 and lot numbers 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, or 19J051. The product is sold in bulk containers from ULTRAtab Laboratories in Highland, NY.
Look for the NDC code 62959-140-00 and lot numbers listed in the recall notice.
The recall notice does not provide a remedy or action steps for this product.
CGMP deviations indicate manufacturing quality issues that could affect product safety, but the exact risk is not specified in the recall.
Affected lots include 18K017, 18L002, 19C064, 19E067, 19F064, 19H053, 19J023, and 19J051.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0530-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0530-2022 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.
