← FDA ENFORCEMENT
D-0357-2025Class II

Somerset Therapeutics Private Limited

Recalling firm
Somerset Therapeutics Private Limited
Product type
Drug
Status
Ongoing
Report date
2025-04-16
Distribution
U.S. Nationwide
Firm state
N/A
Product quantity
23,960 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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)

Code / lot info

NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.