FDA recall D-0169-2025

SOMERSET THERAPEUTICS LLC · Class III · drug

Product

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

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2024-12-16
Report date: 2025-01-08
Termination date: 2025-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0169-2025