D-0169-2025 Class III Terminated
FDA drug recall D-0169-2025 was initiated by SOMERSET THERAPEUTICS LLC on Dec 16, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated Jun 10, 2025). Affected quantity: 5,870 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 8, 2025
- Initiation Date
- Dec 16, 2024
- Termination Date
- Jun 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,870 bottles
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: A240211, Exp. Date April 2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0169-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026