Recall D-1483-2022
Description: Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73
Recall D-1483-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1483-2022 |
Event ID | 90398 |
Distribution | Distributed Nationwide in the USA |
Quantity | 88,500 cups |
Recall Reason | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. |
Drug Classification | Class II |
Drug Code Info | 20220914 |
Recall Initiation Date | 20220607 |
Report Date | 20220914 |
Classification Date | 20220906 |
Address | 3780 Greenway Cir Lawrence, KS 66046-5440 United States |
Recalling Firm | Plastikon Healthcare LLC |
Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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