Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset T...
FDA Recall #D-0169-2025 — Class III — December 16, 2024
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
Reason for Recall
Failed Impurities/Degradation Specifications
Recalling Firm
SOMERSET THERAPEUTICS LLC — Somerset, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
5,870 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: A240211, Exp. Date April 2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated