First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy recalls S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Recalled November 13, 2019 · FDA recall D-0217-2020 · First Royal Care Co. LLC,
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
3x50ml, 6x100ml glass vials
Sold at
Nationwide in the USA
Description
Lack of Assurance of Sterility
Product
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Manufacturer(s)
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →