Reported Jul 15, 2020 · Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC…
Somerset Therapeutics LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SOMERSET THERAPEUTICS LLC · 300 Franklin Square Dr · Somerset, NJ · 08873-4187
Is this the product you have?
Brimonidine Tartrate Opthalmic Solution 0.2%5 mL bottleRx only
- Manufactured forSomerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 Lots # BRM11W9001, BRM11W9002, BRM11W9003, EXP Nov 2020 2 BRM11W9004, BRM11W9005, BRM11W9006, EXP Dec 2020 3 BRM11W9007, BRM11W9008, BRM11W9009, EXP Mar 2021 4 BRM11W9010, BRM11W9011, BRM11W9012, BRM11W9013, EXP Apr 2021 5 BRM11W9014, BRM11W9015, EXP May 2021 - Amount recalled
- 383,437 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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