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FDAMarch 21, 2025drug

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)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility: Media fill with bacterial contamination

What to do

FDA enforcement status: Ongoing

Brands named

somerset therapeutics privatesomersetsomerset therapeutics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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