Recalling firm
SOMERSET THERAPEUTICS LLC
Product type
Drug
Status
Ongoing
Report date
2024-05-29
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
5,578 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Product description
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.
Code / lot info
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
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.