Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
Reported: July 15, 2020 Initiated: June 4, 2020 #D-1375-2020
Product Description
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
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.
Details
- Recalling Firm
- SOMERSET THERAPEUTICS LLC
- Units Affected
- 22,788 bottles
- Distribution
- Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01. Recalled by SOMERSET THERAPEUTICS LLC. Units affected: 22,788 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Low. Recall number: D-1375-2020.
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