Recalls / Class II
Class IID-0637-2022
Product
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
- Affected lot / code info
- Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23
Why it was recalled
Failed impurities/degradation specifications
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 44 bottles
- Distribution pattern
- Florida
Timeline
- Recall initiated
- 2022-02-17
- FDA classified
- 2022-02-25
- Posted by FDA
- 2022-03-09
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0637-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.