ALUMINUM HYDROXIDE Recall D-0871-2022
Description: Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
ALUMINUM HYDROXIDE Recall D-0871-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0871-2022 |
| Event ID | 89879 |
| Brand | MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE |
| Generic Name | MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE |
| Manufacturer | MAGNESIUM HYDROXIDE/ALUMINUM HYDROXICE/SIMETHICONE |
| Original Package? | 1 |
| Active Substance | ALUMINUM HYDROXIDE DIMETHICONE |
| Drug Route | ORAL |
| Distribution | Distributed in Indiana for further distribution in the USA. |
| Quantity | 106,400 Unit Dose cups |
| Recall Reason | CGMP Deviations: Failure to properly investigate failed microbial testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220525 |
| Product NDC | 0904-6838 0904-6839 |
| Product NUI | N0000010282 |
| Drug UPC | 0309046839736 0309046838739 |
| Pharma Class (PE) | Skin Barrier Activity [PE] |
| Recall Initiation Date | 20220324 |
| Report Date | 20220525 |
| Classification Date | 20220513 |
| Address | 3780 Greenway Cir Lawrence, KS 66046-5440 United States |
| Recalling Firm | Plastikon Healthcare LLC |
| Initial Notification | Press Release |
| Unique Ingredient Identifier | 92RU3N3Y1O 5QB0T2IUN0 |
| Drug Application Number | part331 |
| Structured Product Labeling (SPL ID) | d35bc479-bb6f-c173-e053-2995a90a3e62 |
| Structured Product Labeling (SPL Set ID) | 97978a75-bf85-ba66-e053-2995a90a3b2d |
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