FDARecalled May 29, 2024 · #D-0506-2024
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutic...
Hazard
Class II — temporary health risk
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Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). Classification: Class II Distribution: Nationwide within the United States
Product details
- Product
- Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
- Type
- Drugs
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Model numbers
- —
- UPCs
- —