D-0217-2020 Class II Terminated
FDA drug recall D-0217-2020 was initiated by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy on August 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated April 13, 2023). Affected quantity: 3x50ml, 6x100ml glass vials.
Recall Details
- Product Type
- Drugs
- Report Date
- November 13, 2019
- Initiation Date
- August 12, 2019
- Termination Date
- April 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3x50ml, 6x100ml glass vials
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
Distribution Pattern
Nationwide in the USA
Code Information
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;