FDA-Drug2019-11-13Class II

S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Hazard

Lack of Assurance of Sterility

Sold states
Nationwide in the USA
Affected count
18x10 ml and 1x5 ml glass vials
Manufactured in
6828 E Brown Rd Ste 101, N/A, Mesa, AZ, United States
Products
S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0207-2020

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