FDAFDA · Food and drugs·Recall number D-0369-2025
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.
Published April 30, 2025 · Recall initiated: April 2, 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. Bacterial contamination detected in some media fill units
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Amerisource Health Services LLC
- Distributor
- Nationwide in the USA
- UPC
- 0368001578592
- Lot
- A240482B, EXP 08/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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