Recalls / Class II
Class IID-0152-2020
Product
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
- Affected lot / code info
- Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Address
- 24416 N 19th Ave, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 808 droptainers
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-09-18
- FDA classified
- 2019-10-18
- Posted by FDA
- 2019-10-30
- Terminated
- 2019-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0152-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.