Why it was recalled
Lack of Assurance of Sterility
Product description
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lot numbers, UPCs & expiration codes
Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0692-2021
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jul 9, 2021
- FDA report date
- Jul 28, 2021
- Quantity
- 728 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Innoveix Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0692-2021, exactly as published.
Show all FDA fields
- City
- Addison
- State
- TX
- Status
- Completed
- Country
- United States
- Event ID
- 88159
- Address
- 3790 Arapaho Rd
- Code information
- Lot #: SIP215 Exp. 01/14/2022, SIP220 Exp. 01/23/2022, SIP210 Exp. 12/15/2021
- Postal code
- 75001-4311
- Report date
- Jul 28, 2021
- Product type
- Drugs
- Recall number
- D-0692-2021
- Classification
- Class II
- Recalling firm
- Innoveix Pharmaceuticals Inc
- Product quantity
- 728 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jul 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 20, 2021