Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01

Recall Number: D-0169-2025

Firm: SOMERSET THERAPEUTICS LLC

Classification: Class III

Status: Terminated

Report Date: 20250108

Initiation Date: 20241216

Termination Date: 20250610

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01