Status
Ongoing
Drug Enforcement D-0358-2025
Lack of Assurance of Sterility: Media fill with bacterial contamination
Classification
Class II
Report Date
April 16, 2025
Termination Date
—
Product Information
- Product description
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
- Product quantity
- 240 vials
- Reason for recall
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. Nationwide
Location & Firm
- Recalling firm
- Somerset Therapeutics Private Limited
- Address
-
54/1 Budihal Village, N/A
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0358-2025
- Event ID
- 96569
- Recall initiation date
- March 21, 2025
- Center classification date
- April 8, 2025
- Code info
- A240482D, exp. date 08/2026
- More code info
- —