Cardinal Healthcare recalls Leader Nasal Decon: 18-tablet packs exposed to temperatures outside labeled storage. No remedy stated in official notice.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) tablets because they may have been exposed to temperatures outside the labeled storage conditions. This could potentially affect product stability, though no specific harm is reported in the recall notice.
The product may have been exposed to temperatures outside the labeled storage conditions, which could affect its stability. This is a CGMP (current good manufacturing practice) deviation that might lead to product degradation, though no specific harm is mentioned in the recall notice.
People who own or use Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) 18-tablet packs distributed by Cardinal Healthcare. Those storing the product in uncontrolled environments may be at higher risk.
Check for Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) 18-tablet packs with NDC code 70000-0126-1 and batch number P125514. The product was distributed by Cardinal Healthcare from Dublin, Ohio.
Identify if your product matches the description: Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 tablets per carton, NDC 70000-0126-1, batch P125514.
The official recall notice does not state any remedy.
The product may have been exposed to temperatures outside the labeled storage conditions, which is a CGMP deviation.
Look for Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) 18-tablet packs with NDC code 70000-0126-1 and batch number P125514.
We’ve drafted a message you can send Cardinal Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0186-2024 — Cardinal Healthcare Cardinal Healthcare Hello, I own a Cardinal Healthcare that is covered by recall D-0186-2024 from Cardinal Healthcare. 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.
