FDA Recall Ongoing Historical recordClass II
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
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Published
- April 30, 2025
- Distribution
- Nationwide
