Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin,
Summary
The FDA issued a Class II for Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, by CARDINAL HEALTHCARE. Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions..
Details
Source
Drug Recall
External ID
D-0186-2024
Action Date
2024-01-03
Status
Terminated
Category
drug
Product Description
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
Lot/Code Info: Batch P125514
Quantity Affected: 1 unit
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-26
Company
Dublin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 74 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
CARDINAL HEALTHCARE has 42 FDA actions in our database, including 42 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CARDINAL HEALTHCARE) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CARDINAL HEALTHCARE have FDA actions?
CARDINAL HEALTHCARE has 42 FDA actions in our database, including 42 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0186-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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