Essential Wellness Pharma Recalls TRIMIX #2 Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.
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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in compounded sterile preparations, which poses a significant risk of serious injury or infection.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials. The recall covers all compounded sterile preparations within their expiry dates.
The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished drugs. The affected lots include # 070815, 071715, 073115, 080415, and 080615, with expiration dates ranging from September 2015 to October 2015.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 5
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 (10)
- Lot # 070815
- Exp 09/08/2015
- 071715
- Exp 09/17/2015
- 073115
- Exp 10/012015
- 080415
- Exp 10/04/2015
- and 080615
- Exp 10/06/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 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 39 products in this recall →Related recalls
Same manufacturer · Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
See all →- SevereEssential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereEssential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereEssential Wellness Pharma Recalls Sermorelin Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- Severe
- SevereEssential Wellness Pharma Recalls Dexamethasone Ointment Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
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
- SevereWells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- HighAssurance Infusion Recalls TRIMIX Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2020-01-22
- SevereAssurance Infusion Recalls TRIMIX Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-01-22
- SeverePharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns
FDA (Drugs) · 2019-06-19
- SevereWells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
- SevereFDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns
FDA (Drugs) · 2017-05-24