Recalls / Class II
Class IID-0210-2019
Product
Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05
- Affected lot / code info
- Lot: 04192018:22 Discard by: 5/17/2018; 04022018:47 Discard by: 4/23/2018; 05102018:77 Discard by: 6/7/2018; 08022018:63 Discard by: 8/30/2018; 08272018:66 Discard by: 9/24/2018
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Pharm D Solutions, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1304 S Loop W, N/A, Houston, Texas 77054-4010
Distribution
- Quantity
- 521 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-10
- FDA classified
- 2018-11-01
- Posted by FDA
- 2018-11-07
- Terminated
- 2021-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0210-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.