NDC 70069-381
Haloperidol Decanoate 50 mg per 1 mL injection
On the label: Somerset Therapeutics, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it, packages it and labels it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Mar 21, 2025 · Class II · Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lots: NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026 - Apr 24, 2024 · Class II · Somerset Therapeutics Llc
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Lots: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Haloperidol: every company that makes it
- Form
- injection, intramuscular
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA209101
- On the market since
- Apr 4, 2019
- Package NDCs
70069-381-0170069-381-10- Official label
- DailyMed (National Library of Medicine), updated Oct 12, 2026
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