Drug Enforcement D-0506-2024

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

Status

Ongoing

Classification

Class II

Report Date

May 29, 2024

Termination Date

—

Product Information

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.
Product 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 initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
SOMERSET THERAPEUTICS LLC
Address
300 Franklin Square Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0506-2024
Event ID
94452
Recall initiation date
April 24, 2024
Center classification date
May 21, 2024
Code info
Lot #: a) A230412A, Exp. Date 07/2025; b)A230412B, Exp. Date 07/2025
More code info
—