ULTRAtab Laboratories recalls bulk calcium carbonate antacid tablets due to CGMP deviations. Consumers should check product codes and lot numbers for affected items.
CGMP Deviations
ULTRAtab Laboratories is recalling a bulk container of Trial Antacid Tablets (Calcium Carbonate 42:0 mg) because of manufacturing quality control issues. This recall does not involve immediate safety risks to consumers but requires checking product details to avoid affected items.
The product was manufactured under CGMP (Current Good Manufacturing Practices) deviations, which means the production process did not meet regulatory standards. This could affect the product's quality but does not pose a direct safety risk to consumers.
Anyone who purchased the bulk container of Trial Antacid Tablets with the specific NDC code 62959-310-00 and product codes M310. The risk is low as the issue relates to manufacturing quality control, not immediate safety hazards.
Check for the NDC code 62959-310-00 and product codes M310 on the bulk container. Affected lots are 19C044 and 19H015.
Look for the NDC code 62959-310-00 and product codes M310 on the bulk container.
No, the recall is due to CGMP deviations, which affect product quality but not immediate safety risks.
Check the product details to see if it matches the affected NDC code and lot numbers. If it does, you may not need to take action as the risk is low.
Look for the NDC code 62959-310-00 and product codes M310 on the bulk container. Affected lots are 19C044 and 19H015.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0541-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0541-2022 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.
