Recall: D-0169-2025

Class III - Minor Violations

Class IIIClassification

2024-12-16Initiated

TerminatedStatus

SOMERSET THERAPEUTICS LLCFirm

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

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.