D-0241-2020 Class II Terminated
FDA drug recall D-0241-2020 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: 24x30 ml 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
- 24x30 ml vials
Product Description
S-MIC 25/50/50MG/ML MDV SOLN, 30ml 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 #: S02142019DH@01, Exp 8/14/19; S03112019DT@04, Exp 09/11/2019, S03192019DT@04, Exp 9/19/19; S04162019DT@15, Exp 10/16/19; S07172019DT@10, Exp 1/17/20; S07232019DH@04, Exp 1/23/20;