Brimonidine Tartrate Opthalmic Solution 0.2% recall: Impurity Out of Spec
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India.…
Why was Brimonidine Tartrate Opthalmic Solution 0.2% 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021
- Product
- Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India.…
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Quantity
- 48,852 bottles
- Distribution
- Nationwide
- Recall date
- July 15, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)