FDAHealthMarch 21, 2025
Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: Blue
⚠️ 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 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
- UPC
- 0368001578592
- Lot code
- NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
Additional details
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 23,960 vials.
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