SOMERSET THERAPEUTICS LLC: Drug Recall
Recall #D-0506-2024 · 04/24/2024
Class II: Risk
Recall Details
- Recall Number
- D-0506-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- SOMERSET THERAPEUTICS LLC
- Status
- Ongoing
- Date Initiated
- 04/24/2024
- Location
- Somerset, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,578 units
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Product Description
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.
Distribution Pattern
Nationwide within the United States
Other Recalls by SOMERSET THERAPEUTICS LLC
- Class III: Low Risk 11/26/2025
- Class III: Low Risk 11/26/2025
- Class III: Low Risk 11/26/2025
- Class III: Low Risk 12/16/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.