D-0225-2020 Class II Terminated
FDA drug recall D-0225-2020 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: 5x30 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
- 5x30 ML vials
Product Description
S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: S05142019DT@09, Exp 8/14/19; S07162019DT@14, Exp 10/16/19; S07232019DH@06, Exp 10/23/19