Drug Recall: Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, M
Amerisource Health Services LLC · April 2, 2025
Reason for Recall
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Product Description
Haloperidol Decanoate Injection, 50mg/mL* , 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 68001-580-41.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
2,110 vials
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0367-2025
Status: ongoing
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