D-0772-2020 Class II Terminated
FDA drug recall D-0772-2020 was initiated by Assurance Infusion on Dec 20, 2019 and is designated Class II. Reason for recall: Lack of sterility assurance. The recall status is terminated (terminated Oct 27, 2021). Affected quantity: 166 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 22, 2020
- Initiation Date
- Dec 20, 2019
- Termination Date
- Oct 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 166 vials
Product Description
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0772-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026