ULTRAtab Laboratories recalls bulk containers of 3-Component Cold Tabs due to CGMP deviations. Affected products include specific NDC numbers and lots. Consumers should contact the manufacturer for details.
CGMP Deviations
ULTRAtab Laboratories is recalling bulk containers of 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) because of CGMP deviations. This recall affects specific product lots and NDC numbers. The hazard involves manufacturing quality issues that could impact product safety.
CGMP deviations refer to failures in the manufacturing process that could lead to unsafe products. These deviations might affect the quality, purity, or safety of the medication, potentially causing harm if used improperly.
People who purchased or have the specific bulk containers with NDC 62959-106-00 and the listed lots (e.g., 18J080, 18L029) are affected. Those using the product for cold relief may be at risk due to manufacturing quality issues.
Check for the product code C106L or C106LA with the specific NDC number 62959-106-00 and the listed bulk lots (e.g., 18J080, 18L029). The product is sold in bulk containers.
Reach out to ULTRAtab Laboratories, Inc. for specific instructions on how to return or dispose of the affected products.
The product code for the recalled items is C106L or C106LA with NDC 62959-106-00.
The affected lots include 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027.
Check the product code and NDC number on your container. The affected products have NDC 62959-106-00 and the listed bulk lots.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0523-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0523-2022 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.
