MORPHINE SULFATE Recall D-0367-2022
Description: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
MORPHINE SULFATE Recall D-0367-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0367-2022 |
| Event ID | 89142 |
| Brand | MORPHINE SULFATE |
| Generic Name | MORPHINE SULFATE |
| Manufacturer | MORPHINE SULFATE |
| Original Package? | 1 |
| Active Substance | MORPHINE SULFATE |
| Drug Route | ORAL |
| Distribution | Nationwide USA |
| Quantity | 10,836 bottles |
| Recall Reason | Labeling: Missing Label |
| Drug Classification | Class III |
| Drug Code Info | 20220119 |
| Product NDC | 50383-965 |
| Recall Initiation Date | 20211203 |
| Report Date | 20220119 |
| Classification Date | 20220113 |
| Address | 1925 W Field Ct Ste 300 Lake Forest, IL 60045-4862 United States |
| Recalling Firm | Akorn, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | X3P646A2J0 |
| Drug Application Number | ANDA208809 |
| Structured Product Labeling (SPL ID) | 29041817-1477-4dcf-8add-64c62e8f6e7c |
| Structured Product Labeling (SPL Set ID) | 431a06fb-b6e3-4aab-a965-6b90ad8b5aa5 |
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