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.

FDA recall notice · announced May 29, 2024 · Somerset Therapeutics

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
Quantity: 5,578 units
Status: Ongoing
Products in this recall event:
- 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, (D-0506-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.