FEXOFENADINE HYDROCHLORIDE Recall D-0342-2022
Description: MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9
FEXOFENADINE HYDROCHLORIDE Recall D-0342-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0342-2022 |
| Event ID | 88384 |
| Brand | FEXOFENADINE HYDROCHLORIDE |
| Generic Name | FEXOFENADINE HCL |
| Manufacturer | FEXOFENADINE HCL |
| Original Package? | 1 |
| Active Substance | FEXOFENADINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA |
| Quantity | 65,796 containers |
| Recall Reason | Out of specification impurity A result obtained during stability testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220112 |
| Product NDC | 0904-6979 |
| Drug UPC | 309046979609 |
| Recall Initiation Date | 20210727 |
| Report Date | 20220112 |
| Classification Date | 20220105 |
| Address | 515 Eastern Ave Allegan, MI 49010-9070 United States |
| Recalling Firm | Perrigo Company PLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 2S068B75ZU |
| Drug Application Number | ANDA076447 |
| Structured Product Labeling (SPL ID) | 5fdb4f82-4381-4d86-adba-ba4a798ab605 |
| Structured Product Labeling (SPL Set ID) | f0ddec5b-27f1-42ec-9276-284d1d2b0181 |
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