Class II
Ongoing
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
This recall is currently active, issued April 16, 2025. It was issued by Somerset Therapeutics Private Limited.
- Recall Initiated
- March 21, 2025
- Posted
- April 16, 2025
- Recall Number
- D-0356-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4956 vials
- Firm Location
- Bengaluru, India
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Distribution
U.S. Nationwide
Lot / Code Info
A240467B, exp. date 07/2026
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