FDAHealthApril 2, 2025
Amerisource Health Services LLC — Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala
⚠️ Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 2, 2025
Nationwide in the USA
What's affected?
- Product
- 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.
- UPC
- 0368001578592
- Lot code
- A240482B, EXP 08/31/2026
Additional details
A240482B, EXP 08/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 143 1x5 vials.
Get Health recall alerts
Delivered to your inbox. Free. No account required.