Reported Jul 15, 2020 · Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 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%15 mL bottleRx only
- Manufactured forSomerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
- Lot codes and dates
Lot #s BRM13W9001BRM13W9002BRM13W9003EXP Dec. 2020: BRM13W9004EXP Apr. 2021
- Amount recalled
- 22,788 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.
Want the full recall guide?
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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