CLASS II Drug recall · Reported 3 Jan 2024 · FDA Enforcement Report
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) recalled
Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg) per, distributed nationwide in the US. The recall was initiated on 26 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0186-2024
- FDA event ID
- 89450
- Recalling firm
- Cardinal Healthcare, Dublin, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jan 2022
- FDA classified
- 26 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 26 Jan 2022 | Recall initiated by company | |
| 26 Dec 2023 | Classified by FDA | +699 days |
| 3 Jan 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Product as listed by the FDA
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which lots are affected?
Batch P125514
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
41 other products · FDA event 89450This product is part of a recall event; the main page for the event is Enoxaparin Sodium Injection recalled by Cardinal Healthcare.
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|---|---|---|---|---|---|
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