Class IIIReported 2025-01-08

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

Recalled by SOMERSET THERAPEUTICS LLC

Reason for Recall

Failed Impurities/Degradation Specifications

Recall Number

D-0169-2025

Classification

Class III

Status

Terminated

Category

drug

Initiated

2024-12-16

Reported

2025-01-08

Distribution

Nationwide within the United States

Code Info

Lot #: A240211, Exp. Date April 2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.