FDAHealthApril 2, 2025
Amerisource Health Services LLC — Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangal
⚠️ 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, 100 mg/mL*, 1 x 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 68001-581-41.
- UPC
- 0368001578592
- Lot code
- A240482A, EXP 08/31/2026
Additional details
A240482A, EXP 08/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,189 vials.
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