FDAFDA · Food and drugs·Recall number 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 Therapeutics, LLC, Hollywood, FL 33024, Made in India.
Published May 29, 2024 · Recall initiated: April 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Distributor
- Nationwide within the United States
- UPC
- 0370069382011
- Lot
- Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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