US Compounding Inc recalls Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Com
Recalled November 25, 2015 · FDA recall D-0274-2016 · 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
862 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
Phenylephrine 10% PF Ophthalmic Solution, 3 mL dropper bottle, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3273-03.
Manufacturer(s)
US Compounding Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →