D-0369-2025 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
- 143 1x5 vials
Product Description
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Distribution Pattern
Nationwide in the USA
Code Information
A240482B, EXP 08/31/2026