The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-301-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns

Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of 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 agency classified this as an FDA Class II recall. According to the rubric, an FDA Class II recall involving a lack of sterility assurance (a significant safety hazard) is categorized as Severe.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling all compounded sterile preparations of BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials. The recall is being initiated due to observations associated with poor sterile production practices that resulted in a lack of sterility assurance for the finished drugs.

The affected product is BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, which is prescription-only. The recall covers specific lots with the following lot numbers and expiration dates: 071015 (Exp 09/10/2015), 072115 (Exp 09/21/2015), and 080715 (Exp 10/07/2015). 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BIMIX INJ 30 mg-1 mg/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 Preparation
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 (6)

  • Lot #: 071015
  • Exp 09/10/2015
  • 072115
  • Exp 09/21/2015
  • and 080715
  • Exp 10/07/2015

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.

See all 39 products in this recall →

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