D-1238-2022 Class II Ongoing
FDA drug recall D-1238-2022 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: 414 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 414 vials
Product Description
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Batch#: a)10142117A2, Exp 4/12/2022; 10272108A1, Exp 4/25/2022; 11302113A2, Exp 5/29/2022; 02252220A1, Exp 8/24/2022; b)10142108A2, Exp 4/12/2022; 12072134A1, Exp 6/5/2022.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1238-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026