The Recall Desk
SevereFDA (Drugs)·D-333-2016·Announced 2015-11-25

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Manufacturer
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Category
Drug — Compounded Sterile Preparations
Hazard
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 →

Same hazard · sterility failure

See all →