D-1374-2020 Class III Terminated
FDA drug recall D-1374-2020 was initiated by SOMERSET THERAPEUTICS LLC on Jun 4, 2020 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. The recall status is terminated (terminated Jun 30, 2023). Affected quantity: 48,852 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 15, 2020
- Initiation Date
- Jun 4, 2020
- Termination Date
- Jun 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,852 bottles
Product Description
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
Reason for Recall
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
Distribution Pattern
Nationwide
Code Information
Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1374-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026