ULTRAtab Laboratories recalls Phenylephrine HCl 5mg tablets due to CGMP deviations. Affected lots from 18M065 to 19J078. No specific remedy stated in official notice.
CGMP Deviations
ULTRAtab Laboratories is recalling Phenylephrine HCl 5mg tablets from specific production lots due to regulatory compliance issues. This recall does not involve immediate safety risks but requires action to prevent potential quality problems.
CGMP deviations refer to failures in the manufacturing process that could result in products not meeting quality standards. This means the recalled tablets might not be safe or effective for medical use, though the exact risk level is not specified in the recall notice.
People who purchased Phenylephrine HCl 5mg tablets from ULTRAtab Laboratories, Inc. in Highland, NY, with NDC 62959-333-00 and product codes M333. Those using the product for medical purposes are most at risk of receiving substandard medication.
Check for the NDC code 62959-333-00 and product code M333 on the packaging. The affected lots are labeled as 18M065 or 19J078.
Identify the NDC code 62959-333-00 and product code M333 on the packaging to confirm if your tablets are affected.
The recall is due to CGMP deviations, which could affect product quality but does not specify a risk of serious injury. The official notice does not mention safety hazards.
The official recall notice does not provide a remedy, so no specific action is required beyond checking if your tablets are affected.
Check the NDC code 62959-333-00 and product code M333 on the packaging. Affected lots are 18M065 or 19J078.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0545-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0545-2022 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.
