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FDARecalled Apr 16, 2025 · #D-0355-2025

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 (...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility: Media fill with bacterial contamination Classification: Class II Distribution: U.S. Nationwide

Product details

Product
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)
Type
Drugs
Manufacturer
Somerset Therapeutics Private Limited
Model numbers
70069-381-01, 70069-381-10
UPCs