Drug Enforcement D-0169-2025

Failed Impurities/Degradation Specifications

Status

Terminated

Classification

Class III

Report Date

January 8, 2025

Termination Date

June 10, 2025

Product Information

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
Product quantity
5,870 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
SOMERSET THERAPEUTICS LLC
Address
300 Franklin Square Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0169-2025
Event ID
95997
Recall initiation date
December 16, 2024
Center classification date
December 31, 2024
Code info
Lot #: A240211, Exp. Date April 2026
More code info
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