FDA-Drug2025-04-30Class II
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.
Amerisource Health Services LLC
Hazard
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Sold states
Nationwide in the USA
Affected count
14,189 vials
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2025Don't want to check this manually?
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