Multi-event June 2020 FDA Recall Brimonidine Tartrate by Somerset Therapeutics Llc
This Multi-event Class III drug recall was voluntarily initiated by Somerset Therapeutics Llc on June 4, 2020 for the product Brimonidine Tartrate. The FDA reported the reason for recall as failed impurities/degradation specification. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1375-2020
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.
06-04-2020
07-15-2020
22,788 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-30-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1373-2020
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.
06-04-2020
07-15-2020
383,437 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-30-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1374-2020
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.
06-04-2020
07-15-2020
48,852 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SOMERSET THERAPEUTICS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-30-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
