FDAFDA · Food and drugs·Recall number D-0356-2025
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
Published April 16, 2025 · Recall initiated: March 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Somerset Therapeutics Private Limited
- Distributor
- U.S. Nationwide
- UPC
- 0368001578592
- Lot
- A240467B, exp. date 07/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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