Recalls / Class II
Class IID-0693-2021
Product
Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Affected lot / code info
- Lot #: AOD205 Exp. 11/09/2021; AOD210 Exp. 11/18/2021; AOD215 Exp. 12/15/2021; AOD220 Exp. 01/20/2022.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Innoveix Pharmaceuticals Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3790 Arapaho Rd, N/A, Addison, Texas 75001-4311
Distribution
- Quantity
- 1,316 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-07-09
- FDA classified
- 2021-07-20
- Posted by FDA
- 2021-07-28
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0693-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.