Why it was recalled
Lack of Sterility Assurance.
Product description
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lot numbers, UPCs & expiration codes
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
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-0157-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 10, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 3905 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Innoveix Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0157-2020, exactly as published.
Show all FDA fields
- City
- Addison
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84006
- Address
- 3790 Arapaho Rd
- Code information
- 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
- Postal code
- 75001-4311
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0157-2020
- Classification
- Class II
- Recalling firm
- Innoveix Pharmaceuticals Inc
- Product quantity
- 3905 vials
- Termination date
- Jan 14, 2022
- Reason for recall
- Lack of Sterility Assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 10, 2019
- Initial firm notification
- Press Release
- Center classification date
- Oct 28, 2019