FDAFDA · Food and drugs·Recall number D-1373-2020
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
Published July 15, 2020 · Recall initiated: June 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BRIMONIDINE TARTRATE
- Manufacturer
- SOMERSET THERAPEUTICS LLC
- Distributor
- Nationwide
- UPC
- 0370069231012
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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