FDAHealthMarch 21, 2025
Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePo
⚠️ Lack of Assurance of Sterility: Media fill with bacterial contamination
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 21, 2025
U.S. Nationwide
What's affected?
- Product
- 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
- UPC
- 0368001578592
- Lot code
- A240467B, exp. date 07/2026
Additional details
A240467B, exp. date 07/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4956 vials.
Get Health recall alerts
Delivered to your inbox. Free. No account required.