FDA Recall D-0506-2024

SOMERSET THERAPEUTICS LLC · Somerset, NJ

Class II Ongoing 750 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.

Lot / code: Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025

Quantity: 5,578 units

Reason for recall

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Recall record

Recall number: D-0506-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2024-04-24
Classified by FDA Center: 2024-05-21
FDA published: 2024-05-29
Recalling firm: SOMERSET THERAPEUTICS LLC
Firm location: Somerset, NJ

Drug identification

Brand name(s): HALOPERIDOL DECANOATE
Generic name(s): HALOPERIDOL DECANOATE
Manufacturer(s): Somerset Therapeutics, LLC
NDC(s): 70069-030, 70069-031, 70069-381, 70069-382, 70069-383, 70069-384
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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