HALOPERIDOL DECANOATE Recall D-0356-2025
Description: Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
HALOPERIDOL DECANOATE Recall D-0356-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0356-2025 |
| Event ID | 96569 |
| Brand | HALOPERIDOL DECANOATE |
| Generic Name | HALOPERIDOL DECANOATE |
| Manufacturer | HALOPERIDOL DECANOATE |
| Original Package? | 1 |
| Active Substance | HALOPERIDOL DECANOATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | U.S. Nationwide |
| Quantity | 4956 vials |
| Recall Reason | Lack of Assurance of Sterility: Media fill with bacterial contamination |
| Drug Classification | Class II |
| Drug Code Info | 20250416 |
| Product NDC | 68001-578 68001-579 68001-580 |
| Drug UPC | 0368001578592 0368001581417 0368001579599 |
| Recall Initiation Date | 20250321 |
| Report Date | 20250416 |
| Classification Date | 20250408 |
| Address | 54/1 Budihal VillageN/A Bengaluru, N/A N/A India |
| Recalling Firm | Somerset Therapeutics Private Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | AC20PJ4101 |
| Drug Application Number | ANDA209101 |
| Structured Product Labeling (SPL ID) | 048557ea-f859-f0f2-e063-6294a90af5ab |
| Structured Product Labeling (SPL Set ID) | f2d14406-2ad4-4c5b-9c24-a026f27b415d |
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