Essential Wellness Pharma Recalls TRIMIX #4 Injection Due to Sterility Concerns
Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.
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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials. The recall is initiated due to observations associated with poor sterile production practices, resulting in a lack of sterility assurance for the finished drugs.
The affected product is identified by Lot # 070715 with an expiration date of 09/07/2015. The recall covers all compounded sterile preparations within expiry. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Affected units
- 1
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 (2)
- Lot #: 070715
- Exp 09/07/2015
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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