Why it was recalled
Lack of sterility assurance.
Product description
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Lot numbers, UPCs & expiration codes
Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020
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-0776-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 358 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Assurance Infusion
Original FDA data
Every field from FDA enforcement report D-0776-2020, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84546
- Address
- 2626 S Loop W Ste 555
- Code information
- Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020
- Postal code
- 77054-2652
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0776-2020
- Classification
- Class II
- Recalling firm
- Assurance Infusion
- Product quantity
- 358 vials
- Termination date
- Oct 27, 2021
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2020