D-0355-2025 Class II Ongoing
FDA drug recall D-0355-2025 was initiated by Somerset Therapeutics Private Limited on March 21, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Media fill with bacterial contamination The recall status is ongoing. Affected quantity: 997 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2025
- Initiation Date
- March 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 997 vials
Product Description
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
Reason for Recall
Lack of Assurance of Sterility: Media fill with bacterial contamination
Distribution Pattern
U.S. Nationwide
Code Information
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026