D-0736-2020 Class II Terminated
FDA drug recall D-0736-2020 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: 2 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
- 2 vials
Product Description
HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
Reason for Recall
Lack of sterility assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lots: 11272019@31 Exp. 12/31/2019; 12022019@19 Exp. 01/05/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0736-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026