Class II
Ongoing
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.
This recall is currently active, issued May 29, 2024. It was issued by Somerset Therapeutics Llc.
- Company
- Somerset Therapeutics Llc
- Recall Initiated
- April 24, 2024
- Posted
- May 29, 2024
- Recall Number
- D-0506-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,578 units
- Firm Location
- Somerset, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
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