Leader Nasal Decongestant PE recalled due to improper storage conditions
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a CGMP procedural deviation involving temperature exposure with no demonstrated product harm. Per the rubric, recalls with theoretical hazards and no reported illness or injury score at most 3; this precautionary recall justifies a Moderate (Score 2) rating.
Plain-English summary
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), distributed in 18-tablet cartons, sold nationwide. The recall was initiated because the products were exposed to temperatures outside of the product's labeled storage conditions, constituting a violation of current Good Manufacturing Practice (CGMP) requirements.
The affected batch is P125514. The product carries NDC number 70000-0126-1 and was distributed by Cardinal Health, Dublin, Ohio.
The recalled product
- Product
- Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Nasal Decongestant
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch P125514
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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