Essential Wellness Pharma Recalls TRIMIX #1 Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.
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. According to the rubric, an FDA Class II recall involving a lack of sterility assurance in a sterile injection product is categorized as Severe (Score 4) due to the significant risk of infection or serious injury.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling TRIMIX #1 Injection, 4.2 mL vials. The recall covers six vials per unit and includes lots 071015, 071715, and 073015, with expiration dates of 09/10/2015, 09/17/2015, and 09/30/2015, respectively. 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 assurance of sterility for the finished compounded sterile preparations.
Consumers and healthcare providers should stop using the affected TRIMIX #1 Injection vials and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 6
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 (6)
- Lot #: 071015
- Exp 09/10/2015
- 071715
- Exp 09/17/2015
- and 073015
- Exp 09/30/2015
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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