Amerisource Health Services LLC recalls Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics
Recalled April 30, 2025 · FDA recall D-0369-2025 · Amerisource Health Services
Hazard
Lack of assurance of sterility. Bacterial contamination detected in some media fill units · FDA Class II
Units
143 1x5 vials
Sold at
Nationwide in the USA
Description
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
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.
Manufacturer(s)
Amerisource Health Services LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →