D-0157-2020 Class II Terminated
FDA drug recall D-0157-2020 was initiated by Innoveix Pharmaceuticals Inc on Oct 10, 2019 and is designated Class II. Reason for recall: Lack of Sterility Assurance. The recall status is terminated (terminated Jan 14, 2022). Affected quantity: 3905 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 6, 2019
- Initiation Date
- Oct 10, 2019
- Termination Date
- Jan 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3905 vials
Product Description
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason for Recall
Lack of Sterility Assurance.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: INX 530 Exp. 11/6/19; INX 535 Exp. 11/15/19; INX 540 Exp. 2/1/20; INX 545 Exp. 2/15/20; INX 550 Exp. 3/9/20; INX 555 Exp. 3/26/20; INX 560 Exp. 5/3/20; INX 565 Exp. 5/18/20; INX 570 Exp. 6/28/20; INX 575 Exp. 7/18/20
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0157-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026