WhichRecall
Class IIReported 2025-04-16

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)

Recalled by Somerset Therapeutics Private Limited

Reason for Recall

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Recall Number
D-0355-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-03-21
Reported
2025-04-16
Distribution
U.S. Nationwide
Code Info
NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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