Ultra Seal Corporation recalls phenylephrine nasal decongestant tablets due to cGMP deviations. Affected lots include AK985: 2-count packets, expiring 10/2022. No specific remedy stated in recall.
cGMP deviations
Ultra Seal Corporation is recalling nasal decongestant tablets containing phenylephrine HCl 5mg due to manufacturing quality control issues. This recall does not specify a remedy or risk of injury to consumers.
The recall mentions cGMP deviations, which are manufacturing quality control issues. However, the specific hazard mechanism is not described in the recall record.
People who purchased the 2-count packets of nasal decongestant tablets from Honeywell Safety Products USA, Smithfield, RI, with lot number AK9859 expiring 10/2022. The recall does not specify who is most at risk.
Check for 2-count packets of nasal decongestant tablets labeled with phenylephrine HCl 5mg. The lot number AK9859, expiring 10/2022, was distributed by Honeywell Safety Products USA in Smithfield, RI.
Identify the lot number and expiration date on the packaging to determine if your product is affected.
The recall states cGMP deviations but does not describe a specific hazard mechanism or risk of injury.
The recall does not specify a remedy or action for affected products.
Look for 2-count packets of nasal decongestant tablets with lot number AK9859 expiring 10/2022, distributed by Honeywell Safety Products USA in Smithfield, RI.
We’ve drafted a message you can send Ultra Seal to request your refund or repair — edit it as you like.
Subject: Recall D-0513-2022 — Ultra Seal Ultra Seal Hello, I own a Ultra Seal that is covered by recall D-0513-2022 from Ultra Seal. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
