Recalls / Class II
Class IID-0158-2020
Product
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Affected lot / code info
- Lot #: INX 910 Exp. 2/7/20; INX 915 Exp. 3/12/20
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
- 413 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-0158-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.