SUCRALFATE Recall D-0749-2022
Description: Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
SUCRALFATE Recall D-0749-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0749-2022 |
| Event ID | 89814 |
| Brand | SUCRALFATE |
| Generic Name | SUCRALFATE |
| Manufacturer | SUCRALFATE |
| Original Package? | 1 |
| Active Substance | SUCRALFATE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 45,940 Unit Dose Cups |
| Recall Reason | Labeling: Label Mix-Up |
| Drug Classification | Class II |
| Drug Code Info | 20220413 |
| Product NDC | 69339-148 |
| Product NUI | N0000175801 M0015420 |
| Pharma Class (EPC) | Aluminum Complex [EPC] |
| Pharma Class (CS) | Organometallic Compounds [CS] |
| Recall Initiation Date | 20220311 |
| Report Date | 20220413 |
| Classification Date | 20220406 |
| Address | 2 Park Way Upper Saddle River, NJ 07458-2345 United States |
| Recalling Firm | DASH Pharmaceuticals LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | XX73205DH5 |
| Drug Application Number | NDA019183 |
| Structured Product Labeling (SPL ID) | 3d0de6fb-6d76-4ad8-8cb6-cabd6d4513f0 |
| Structured Product Labeling (SPL Set ID) | c76c7bcb-d481-43ff-809b-da8e0e88f096 |
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