ULTRAtab Laboratories recalls Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) bulk container due to CGMP deviations. No specific remedy is stated in the recall notice.
CGMP Deviations
ULTRAtab Laboratories is recalling Kramer Novis Tusicof Caplet bulk containers because of CGMP deviations. This means the product may not meet quality standards, but the recall does not specify a remedy.
CGMP deviations indicate the product may not meet quality standards. This could affect safety and effectiveness, but the recall does not specify the exact hazard.
People who own or use the Kramer Novis Tusicof Caplet bulk container with NDC 62959-124-00 are affected. Those who have the product are most at risk.
Check for the Kramer Novis Tusicof Caplet bulk container with NDC 62959-124-00. The product was sold in bulk lots 18K028 from ULTRAtab Laboratories in Highland, NY.
Identify if you have the Kramer Novis Tusicof Caplet bulk container with NDC 62959-124-00.
The recall notice does not state a remedy.
The product code is C119L.
The NDC number is 62959-124-00.
We’ve drafted a message you can send ULTRAtab Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0526-2022 — ULTRAtab Laboratories ULTRAtab Laboratories Hello, I own a ULTRAtab Laboratories that is covered by recall D-0526-2022 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.
