US Compounding Inc recalls Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounde
Recalled November 25, 2015 · FDA recall D-0245-2016 · US Compounding
Hazard
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. · FDA Class II
Units
1,198 bottles
Sold at
Nationwide
Description
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Product
Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For topical ophthalmic use, Rx. only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3044-07
Manufacturer(s)
US Compounding Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →