Drug recall D-0169-2025

Class III Terminated reported Jan 8, 2025

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

Lots and codes

Lot #: A240211, Exp. Date April 2026

Recall details

Recalling firm
SOMERSET THERAPEUTICS LLC, Somerset, NJ
Quantity
5,870 bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
December 16, 2024
Terminated
June 10, 2025

Related products