Recalling firm
CARDINAL HEALTHCARE
Product type
Drug
Status
Terminated
Report date
2024-01-03
Distribution
Nationwide USA
Firm state
OH
Product quantity
1 unit
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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
Code / lot info
Batch P125514
Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.