Recalls / Class II
Class IID-0692-2021
Product
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Affected lot / code info
- Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
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
- 728 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-0692-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.