ACETAMINOPHEN Recall D-0870-2022
Description: MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 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 0904-6846-73.
ACETAMINOPHEN Recall D-0870-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0870-2022 |
| Event ID | 89879 |
| Brand | ACETAMINOPHEN ORAL SOLUTION |
| Generic Name | ACETAMINOPHEN ORAL SOLUTION |
| Manufacturer | ACETAMINOPHEN ORAL SOLUTION |
| Original Package? | 1 |
| Active Substance | ACETAMINOPHEN |
| Drug Route | ORAL |
| Distribution | Distributed in Indiana for further distribution in the USA. |
| Quantity | 5,400 Unit Dose cups |
| Recall Reason | CGMP Deviations: Failure to properly investigate failed microbial testing. |
| Drug Classification | Class II |
| Drug Code Info | 20220525 |
| Product NDC | 0904-6738 0904-6739 0904-6740 |
| Drug UPC | 0309046820765 0309046741725 0309046840725 |
| 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 | TC2D6JAD40 NBZ3QY004S |
| Drug Application Number | part343 |
| Structured Product Labeling (SPL ID) | d35be1c3-5196-1f51-e053-2a95a90a6bc2 |
| Structured Product Labeling (SPL Set ID) | 81f30812-60c2-65c0-e053-2991aa0afed6 |
| Similar To |