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FDARecalled Apr 30, 2025 · #D-0369-2025

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka,...

Hazard

Class II — temporary health risk

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Description

Lack of assurance of sterility. Bacterial contamination detected in some media fill units Classification: Class II Distribution: Nationwide in the USA

Product details

Product
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
Type
Drugs
Manufacturer
Amerisource Health Services LLC
Model numbers
UPCs