Recalls / Class II
Class IID-0157-2020
Product
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Affected lot / code info
- 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
Why it was recalled
Lack of Sterility Assurance.
Recalling firm
- Firm
- Innoveix Pharmaceuticals Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 3790 Arapaho Rd, Addison, Texas 75001-4311
Distribution
- Quantity
- 3905 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-10-10
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2022-01-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0157-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.