D-0368-2025 Class II Ongoing
FDA drug recall D-0368-2025 was initiated by Amerisource Health Services LLC on April 2, 2025 and is designated Class II. Reason for recall: Lack of assurance of sterility. Bacterial contamination detected in some media fill units The recall status is ongoing. Affected quantity: 14,189 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- April 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,189 vials
Product Description
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Distribution Pattern
Nationwide in the USA
Code Information
A240482A, EXP 08/31/2026