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FDARecalled Apr 30, 2025 · #D-0368-2025

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

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, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
Type
Drugs
Manufacturer
Amerisource Health Services LLC
Model numbers
UPCs