Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somer
Summary
The FDA issued a Class III for Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufacture by SOMERSET THERAPEUTICS LLC. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0169-2025
Action Date
2025-01-08
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: A240211, Exp. Date April 2026
Quantity Affected: 5,870 bottles
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-16
Company
Somerset, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SOMERSET THERAPEUTICS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SOMERSET THERAPEUTICS LLC have FDA actions?
SOMERSET THERAPEUTICS LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0169-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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