PHENYLEPHRINE HYDROCHLORIDE Recall D-0186-2024
Description: Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
PHENYLEPHRINE HYDROCHLORIDE Recall D-0186-2024 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0186-2024 |
| Event ID | 89450 |
| Brand | NASAL DECONGESTANT PE |
| Generic Name | PHENYLEPHRINE HCL |
| Manufacturer | PHENYLEPHRINE HCL |
| Original Package? | 1 |
| Active Substance | PHENYLEPHRINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 1 unit |
| Recall Reason | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| Drug Classification | Class II |
| Drug Code Info | 20240103 |
| Product NDC | 70000-0126 |
| Drug UPC | 0096295129496 |
| Recall Initiation Date | 20220126 |
| Report Date | 20240103 |
| Classification Date | 20231226 |
| Address | 7200 Cardinal Pl W Dublin, OH 43017-1094 United States |
| Recalling Firm | CARDINAL HEALTHCARE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 04JA59TNSJ |
| Drug Application Number | M012 |
| Structured Product Labeling (SPL ID) | 0d1ab708-9b21-4ac6-8846-fee9967b09d4 |
| Structured Product Labeling (SPL Set ID) | 0e804d71-1a61-4131-9b00-fde3ada7c7f8 |
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