D-0223-2020 Class II Terminated
FDA drug recall D-0223-2020 was initiated by First Royal Care Co. LLC, Dba Red Mountain Compounding Pharmacy on Aug 12, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Apr 13, 2023). Affected quantity: 1, 3 ml prefilled syringe.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 13, 2019
- Initiation Date
- Aug 12, 2019
- Termination Date
- Apr 13, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1, 3 ml prefilled syringe
Product Description
S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: S07262019DH@02, Exp 8/26/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0223-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026