S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Reported: November 13, 2019 Initiated: August 12, 2019 #D-0217-2020
Product Description
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.
Reason for Recall
Lack of Assurance of Sterility
Details
- Units Affected
- 3x50ml, 6x100ml glass vials
- Distribution
- Nationwide in the USA
- Location
- Mesa, AZ
Frequently Asked Questions
What product was recalled? ▼
S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX.. Recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy. Units affected: 3x50ml, 6x100ml glass vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 13, 2019. Severity: Moderate. Recall number: D-0217-2020.
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