D-0506-2024 Class II Ongoing
FDA drug recall D-0506-2024 was initiated by SOMERSET THERAPEUTICS LLC on April 24, 2024 and is designated Class II. Reason for recall: Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). The recall status is ongoing. Affected quantity: 5,578 units.
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2024
- Initiation Date
- April 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,578 units
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.
Reason for Recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025