Haloperidol Decanoate Injection 100mg/mL recalled over sterility concerns
- Recall date
- March 21, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited…
- Recall number
- D-0357-2025
- FDA classification
- Class II
- Brand / firm
- Somerset Therapeutics Private Limited
- Sold / distributed
- U.S. Nationwide
Why it was recalled
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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)
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