FDARecalled Apr 30, 2025 · #D-0367-2025
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...
Hazard
Class II — temporary health risk
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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, 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.
- Type
- Drugs
- Manufacturer
- Amerisource Health Services LLC
- Model numbers
- —
- UPCs
- —