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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- SOMERSET THERAPEUTICS LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1373-2020
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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
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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.