Assurance Infusion Recalls Trimix-A Injection Vials Due to Sterility Concerns
Assurance Infusion is recalling 10 vials of Trimix-A injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Assurance Infusion is recalling 10 vials of TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product is identified by Lot 07082019@31 with an expiration date of 01/04/2020. The recall covers distribution nationwide within the United States.
Consumers and healthcare providers should stop using the recalled product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 07082019@31 Exp. 01/04/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 118 products in this recall →Related recalls
Same manufacturer · Assurance Infusion
See all →- SevereAssurance Infusion Recalls Buprenorphine and Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Hydromorphone Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Morphine Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls Buprenorphine and Morphine Injection Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighTRI-MIX 30/1/20 Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- HighInjectable Medication TRI-MIX Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-09-21
- SevereWells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- HighTRI-MIX 50/2.5/25 Injectable recalled for lack of sterility assurance
FDA (Drugs) · 2022-09-21
- SevereFDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns
FDA (Drugs) · 2017-05-24
- HighTRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
FDA (Drugs) · 2022-09-21