Reported Nov 13, 2019 · Terminated
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · 6828 E Brown Rd Ste 101 · Mesa, AZ · 85207-3761
Is this the product you have?
- S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
- Lot codes and dates
Lot #: a) S04232019DT@07Exp 8/23/19S07302019DH@09Exp 11/30/19b) S05142019DT@14Exp 9/14/19S06182019DH@30Exp 10/18/19S06182019DH@13Exp 10/18/19
- Amount recalled
- 3x50ml, 6x100ml glass vials
This recall covers 100 products
The agency filed one notice per product. You are reading one of them; the other 99 are below.
87 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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