Recalls / Class III
Class IIID-1373-2020
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
- Brand name
- Brimonidine Tartrate
- Generic name
- Brimonidine Tartrate
- Active ingredient
- Brimonidine Tartrate
- Route
- Ophthalmic
- NDCs
- 70069-231, 70069-232, 70069-233
- FDA application
- ANDA208992
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- SOMERSET THERAPEUTICS LLC
- Manufacturer
- Somerset Therapeutics, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Franklin Square Dr, Somerset, New Jersey 08873-4187
Distribution
- Quantity
- 383,437 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-06-04
- FDA classified
- 2020-07-07
- Posted by FDA
- 2020-07-15
- Terminated
- 2023-06-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1373-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.