HALOPERIDOL DECANOATE Recall D-0506-2024
Description: Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
HALOPERIDOL DECANOATE Recall D-0506-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0506-2024 |
| Event ID | 94452 |
| Brand | HALOPERIDOL DECANOATE |
| Generic Name | HALOPERIDOL DECANOATE |
| Manufacturer | HALOPERIDOL DECANOATE |
| Original Package? | 1 |
| Active Substance | HALOPERIDOL DECANOATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 5,578 units |
| Recall Reason | Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). |
| Drug Classification | Class II |
| Drug Code Info | 20240529 |
| Product NDC | 70069-030 70069-031 70069-381 |
| Drug UPC | 0370069382011 0370069383018 0370069031018 |
| Recall Initiation Date | 20240424 |
| Report Date | 20240529 |
| Classification Date | 20240521 |
| Address | 300 Franklin Square Dr Somerset, NJ 08873-4187 United States |
| Recalling Firm | SOMERSET THERAPEUTICS LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | AC20PJ4101 |
| Drug Application Number | ANDA209101 |
| Structured Product Labeling (SPL ID) | f6d888a0-65a7-4073-8671-b00b4bfaff4c |
| Structured Product Labeling (SPL Set ID) | f2bff27f-929f-4f7d-b3eb-084ebc2a885f |
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