April 2024 FDA Recall Haloperidol Decanoate by Somerset Therapeutics Llc
D-0506-2024 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Somerset Therapeutics Llc on April 24, 2024 for the product Haloperidol Decanoate. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0506-2024
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
04-24-2024
05-29-2024
5,578 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
