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.
Product description
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
Lot numbers, UPCs & expiration codes
Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1374-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 4, 2020
- FDA report date
- Jul 15, 2020
- Quantity
- 48,852 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOMERSET THERAPEUTICS LLC
Original FDA data
Every field from FDA enforcement report D-1374-2020, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85826
- Address
- 300 Franklin Square Dr
- Code information
- Lots # BRM12W9001, EXP 2020; BRM12W9002, BRM12W9003, EXP Dec. 2020; BRM12W9004, EXP Apr. 2021
- Postal code
- 08873-4187
- Report date
- Jul 15, 2020
- Product type
- Drugs
- Recall number
- D-1374-2020
- Classification
- Class III
- Recalling firm
- SOMERSET THERAPEUTICS LLC
- Product quantity
- 48,852 bottles
- Termination date
- Jun 30, 2023
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 4, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2020