ULTRAtab Laboratories recalls bulk cold tabs with acetaminophen, guaifenesin, dextromethorphan, and phenylephrine due to CGMP deviations. Consumers should check product codes and lots for affected items.
CGMP Deviations
ULTRAtab Laboratories is recalling bulk cold tabs that contain acetaminophen, guaifenesin, dextromethorphan, and phenylephrine. The recall is due to CGMP deviations, which means the products were made without following proper quality control standards.
CGMP deviations refer to failures in the manufacturing process that do not meet the required quality standards. This could mean the product contains harmful levels of impurities or is not stable, potentially causing health issues if consumed.
People who purchased the bulk cold tabs with the specific product codes and lots listed in the recall notice are affected. Those using the product for cold relief may be at risk if the product was not properly manufactured.
Check the product code (C107L, C107LB, or C107LA) and the specific bulk lot numbers listed in the recall notice. The product is sold in bulk containers from ULTRAtab Laboratories in Highland, NY.
Identify the product code and lot numbers from the recall notice to confirm if your item is affected.
The product was manufactured with CGMP deviations, meaning it did not meet the required quality control standards.
Check the product code and lot numbers to see if it is affected. If it is, you should stop using it and contact ULTRAtab Laboratories for further instructions.
The recall notice does not specify the risk of serious injury, so the danger level is unknown.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0524-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0524-2022 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.
