Home / Recalls / SOMERSET THERAPEUTICS LLC / D-0506-2024

D-0506-2024 Class II Ongoing

Recalled by SOMERSET THERAPEUTICS LLC — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
May 29, 2024
Initiation Date
April 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,578 units

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.

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Code Information

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

Other recalls by SOMERSET THERAPEUTICS LLC

  • D-0238-2026 Class III — Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multipl (November 26, 2025)
  • D-0237-2026 Class III — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-do (November 26, 2025)
  • D-0236-2026 Class III — Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dos (November 26, 2025)
  • D-0169-2025 Class III — Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufacture (December 16, 2024)
  • D-1375-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1374-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufacture (June 4, 2020)
  • D-1373-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured (June 4, 2020)