Brimonidine Tartrate Solution/ Drops
FDA Recall NDC 70069-232
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Brimonidine Tartrate (NDC 70069-232). A significant event, classified as Class III, was initiated on Jun 04, 2020 by Somerset Therapeutics, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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.
Jun 04, 2020
Jul 15, 2020
22,788 bottles
Recall Profile & Regulatory Data
Event ID
85826
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 30, 2023
Product Description
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
Batch or Lot Expiration Information
Lot# s BRM13W9001, BRM13W9002, BRM13W9003, EXP Dec. 2020: BRM13W9004, EXP Apr. 2021.
Affected Packages Involved in this Recall
70069-231-01Product
70069-232-01Product
70069-233-01Product
Class III Terminated
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.
Jun 04, 2020
Jul 15, 2020
383,437 bottles
Recall Profile & Regulatory Data
Event ID
85826
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 30, 2023
Product Description
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
Batch or Lot Expiration Information
Lot# Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020; BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020; BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021; BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021; BRM11W9014, BRM11W9015, EXP May 2021
Affected Packages Involved in this Recall
70069-231-01Product
70069-232-01Product
70069-233-01Product
Class III Terminated
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.
Jun 04, 2020
Jul 15, 2020
48,852 bottles
Recall Profile & Regulatory Data
Event ID
85826
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 30, 2023
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
Batch or Lot Expiration Information
Lot# Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021
Affected Packages Involved in this Recall
70069-231-01Product
70069-232-01Product
70069-233-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
