FDA-Drug2025-04-16Class II
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)
Somerset Therapeutics Private Limited
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
Sold states
U.S. Nationwide
Affected count
23,960 vials
Manufactured in
54/1 Budihal Village, N/A, Bengaluru, N/A, India
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0357-2025Don't want to check this manually?
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