Home / Recalls / SOMERSET THERAPEUTICS LLC / D-1374-2020

D-1374-2020 Class III Terminated

Recalled by SOMERSET THERAPEUTICS LLC — Somerset, NJ

Recall Details

Product Type
Drugs
Report Date
July 15, 2020
Initiation Date
June 4, 2020
Termination Date
June 30, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48,852 bottles

Product Description

Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01

Reason for Recall

Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.

Distribution Pattern

Nationwide

Code Information

Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021

Other recalls by SOMERSET THERAPEUTICS LLC

  • D-0237-2026 Class III — Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-do (November 26, 2025)
  • 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-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-0506-2024 Class II — Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials ( (April 24, 2024)
  • D-1373-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured (June 4, 2020)
  • D-1375-2020 Class III — Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufacture (June 4, 2020)