NDC 68001-581
Haloperidol Decanoate 100 mg per 1 mL injection
On the label: BluePoint Laboratories..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Somerset Therapeutics Private Limited | Bengaluru, India | Makes it, tests it and packages it | Serious problems, FDA actionFeb 21, 2025 · 10 inspections, 4 with FDA action |
Recalls
- Apr 2, 2025 · Class II · Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lots: A240467B, EXP 07/31/2026 - Apr 2, 2025 · Class II · Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lots: A240482A, EXP 08/31/2026 - Apr 2, 2025 · Class II · Amerisource Health Services LLC
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Lots: A240482B, EXP 08/31/2026 - Mar 21, 2025 · Class II · Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lots: A240467B, exp. date 07/2026 - Mar 21, 2025 · Class II · Somerset Therapeutics Private Limited
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lots: NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
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
- 100 mg per 1 mL
- Approval
- ANDA ANDA209101
- On the market since
- Jul 29, 2023
- Package NDCs
68001-581-4168001-581-4868001-581-82- Official label
- DailyMed (National Library of Medicine), updated Sep 11, 2023
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