US Compounding Inc recalls Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compoundi
Recalled November 25, 2015 · FDA recall D-0289-2016 · 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
1,833 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
Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
Manufacturer(s)
US Compounding Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →