D-1197-2022 Class II Ongoing
FDA drug recall D-1197-2022 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: 39.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39
Product Description
Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Batch #: 12032113A2, Exp 6/1/2022; 01102206A1, Exp 7/9/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1197-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026