Recalls / Class II
Class IID-0776-2020
Product
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Affected lot / code info
- 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
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Assurance Infusion
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2626 S Loop W Ste 555, Houston, Texas 77054-2652
Distribution
- Quantity
- 358 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-12-20
- FDA classified
- 2020-01-13
- Posted by FDA
- 2020-01-22
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0776-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.