Essential Wellness Pharma Recalls TRIMIX #3 Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
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 recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a lack of sterility assurance (a significant safety risk) corresponds to a Severe severity score.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials. The recall covers two specific lots: Lot #070915 (Exp 09/09/2015) and Lot #080315 (Exp 10/03/2015). The product was distributed nationwide.
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 compounded sterile preparations.
Consumers who have these specific vials should stop using them and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Hazard
- Affected units
- 2
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 (4)
- Lot #: 070915
- Exp 09/09/2015
- and 080315
- Exp 10/03/2015
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.
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