Drug Enforcement D-0357-2025

Lack of Assurance of Sterility: Media fill with bacterial contamination

Status

Ongoing

Classification

Class II

Report Date

April 16, 2025

Termination Date

—

Product Information

Product description
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
Product quantity
23,960 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-0357-2025
Event ID
96569
Recall initiation date
March 21, 2025
Center classification date
April 8, 2025
Code info
NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026
More code info
—