ULTRAtab Laboratories recalls bulk phenylephrine HCl 5mg tablets due to CGMP deviations. Affected lots: 19A070, 19B080, 19J043. No specific remedy stated in official notice.
CGMP Deviations
ULTRAtab Laboratories is recalling bulk phenylephrine HCl 5mg tablets that were produced with CGMP deviations. This recall is due to manufacturing issues that may affect product quality, though no specific safety risks or remedy are mentioned in the official notice.
CGMP deviations refer to manufacturing process failures that could lead to product quality issues. These deviations may affect the tablet's effectiveness or safety, but the official notice does not specify how they could cause harm in normal use.
Anyone who purchased the bulk containers of phenylephrine HCl 5mg tablets with lot numbers 19A070, 19B080, or 19J043 from ULTRAtab Laboratories. Healthcare professionals using these tablets for medical purposes are most at risk due to potential quality issues.
Check for the product name 'Coated Phenylephrine HCl 5mg Tablet' with NDC code 62959-338-00. Look for lot numbers 19A070, 19B080, or 19J043 on the container.
Identify the lot number on the container to determine if it matches 19A070, 19B080, or 19J043.
The official notice does not state any remedy for this recall.
CGMP deviations refer to manufacturing process failures that could affect product quality, but the official notice does not specify how they could cause harm in normal use.
Lot numbers 19A070, 19B080, and 19J043 are affected.
We’ve drafted a message you can send ULTRAtab to request your refund or repair — edit it as you like.
Subject: Recall D-0546-2022 — ULTRAtab ULTRAtab Hello, I own a ULTRAtab that is covered by recall D-0546-2022 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.
