Class IIReported 2025-04-16

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

Recall Number

D-0357-2025

Classification

Class II

Status

Ongoing