D-1243-2022 Class II Ongoing
FDA drug recall D-1243-2022 was initiated by TMC Acquisition LLC Dba Tailor Made Compounding on Mar 7, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 485 Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 485 Vials
Product Description
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Batch#: a) 01122204A1, Exp 4/12/2022; 02192214A1, Exp 5/20/2022; b) 12142122A2, Exp. 3/14/2022; 12282118A2, Exp 3/28/2022; 01112203A1, Exp 4/11/2022; 01122208A1, Exp 4/12/2022; 01202211A2, Exp 4/20/2022; 02032205A1, Exp 5/4/2022; 02192212A1, Exp 5/20/2022; 03042201A1, Exp 6/2/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1243-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026