FDA-Drug2025-04-16Class II
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Somerset Therapeutics Private Limited
Hazard
Lack of Assurance of Sterility: Media fill with bacterial contamination
Sold states
U.S. Nationwide
Affected count
997 vials
Manufactured in
54/1 Budihal Village, N/A, Bengaluru, N/A, India
Products
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0355-2025Don't want to check this manually?
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