PlainRecalls
FDA Drug Moderate Class II Terminated

Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1

Reported: January 3, 2024 Initiated: January 26, 2022 #D-0186-2024

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

Reason for Recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Details

Recalling Firm
CARDINAL HEALTHCARE
Units Affected
1 unit
Distribution
Nationwide USA
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1. Recalled by CARDINAL HEALTHCARE. Units affected: 1 unit.
Why was this product recalled?
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 3, 2024. Severity: Moderate. Recall number: D-0186-2024.