D-0367-2025 Class II Ongoing
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
- 2,110 vials
Product Description
Haloperidol Decanoate Injection, 50mg/mL* , 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 68001-580-41.
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Distribution Pattern
Nationwide in the USA
Code Information
A240467B, EXP 07/31/2026