Status
Ongoing
Drug Enforcement D-0368-2025
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Classification
Class II
Report Date
April 30, 2025
Termination Date
—
Product Information
- Product description
- Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
- Product quantity
- 14,189 vials
- Reason for recall
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Amerisource Health Services LLC
- Address
-
2550 John Glenn Ave Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0368-2025
- Event ID
- 96636
- Recall initiation date
- April 2, 2025
- Center classification date
- April 18, 2025
- Code info
- A240482A, EXP 08/31/2026
- More code info
- —