S-edetate Calcium 300mg/ml INJ Soln recall: Sterility Concern
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Why was S-edetate Calcium 300mg/ml INJ Soln recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) S04232019DT@07, Exp 8/23/19; S07302019DH@09, Exp 11/30/19, b) S05142019DT@14, Exp 9/14/19; S06182019DH@30, Exp 10/18/19; S06182019DH@13, Exp 10/18/19;
- Product
- S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
- Recalling firm
- First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
- Quantity
- 3x50ml, 6x100ml glass vials
- Distribution
- Nationwide in the USA
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)