FDAHealthApril 2, 2025
Amerisource Health Services LLC — Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Banga
⚠️ 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, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
- UPC
- 0368001578592
- Lot code
- A240467B, EXP 07/31/2026
Additional details
A240467B, EXP 07/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,110 vials.
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