ULTRAtab Laboratories recalls bulk acetaminophen 325mg with phenylephrine 5mg tablets produced with CGMP deviations. Consumers should contact the company for details on affected lots.
CGMP Deviations
ULTRAtab Laboratories is recalling bulk containers of acetaminophen 325mg with phenylephrine 5mg tablets due to manufacturing quality control issues. This recall affects products made in specific lots and may pose risks from improper production standards.
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. These deviations might result in tablets that do not meet safety standards, potentially causing health risks if consumed.
People who purchased or use ULTRAtab's bulk acetaminophen/phenylephrine tablets in the specified lots are affected. Those using these products for pain or cold relief may be at risk if the tablets were produced with quality control deviations.
Check for the product code C134LC and lot numbers 18K055, 18M081, 19A097, 19B024, 19C054, 19E092, or 19G094 on the packaging. The product is sold as a bulk container from ULTRAtab Laboratories in Highland, NY.
Look for the product code C134LC and specific lot numbers on the packaging to confirm if the item is affected.
The hazard is CGMP deviations, which means the tablets were produced with quality control issues that could affect safety.
Check for the product code C134LC and lot numbers 18K055, 18M081, 19A097, 19B024, 19C054, 19E092, or 19G094 on the packaging.
The recall record does not specify a remedy, so contact ULTRAtab Laboratories for further instructions.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0528-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0528-2022 from ULTRAtab. 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.
