CHLORPHENIRAMINE MALEATE Recall D-0029-2025
Description: Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
CHLORPHENIRAMINE MALEATE Recall D-0029-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0029-2025 |
| Event ID | 95590 |
| Brand | CHLORPHENIRAMINE MALEATE 4MG |
| Generic Name | CHLORPHENIRAMINE MALEATE 4MG |
| Manufacturer | CHLORPHENIRAMINE MALEATE 4MG |
| Original Package? | 1 |
| Active Substance | CHLORPHENIRAMINE MALEATE |
| Drug Route | ORAL |
| Distribution | Product was shipped to two private label customers ( OH & MO) as a final packaged product. |
| Quantity | 4,901 cases/24 count each case |
| Recall Reason | Superpotent Drug: Stability failure for assay at 6 months test time-point. |
| Drug Classification | Class II |
| Drug Code Info | 20241106 |
| Product NDC | 53185-277 |
| Drug UPC | 0092617099706 |
| Recall Initiation Date | 20241021 |
| Report Date | 20241106 |
| Classification Date | 20241030 |
| Address | 75 N Industry CtN/A Deer Park, NY 11729-4601 United States |
| Recalling Firm | BLI International, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | V1Q0O9OJ9Z |
| Drug Application Number | M012 |
| Structured Product Labeling (SPL ID) | 3bbe161c-4342-40b5-82b6-5270ef0e31d3 |
| Structured Product Labeling (SPL Set ID) | 4d974959-25fc-4707-9b72-9afbf47b76f1 |
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