D-0261-2020 Class II Terminated
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
- 10 50 ml vials
Product Description
S-EDETATE DISODIUM 15% INJ, packaged in 50ml 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 #:S07232019DH@14 Exp 8/23/19; S07162019DT@06 Exp 8/16/19; S07172019DT@04 Exp 8/17/19