The Recall Desk
SevereFDA (Drugs)·D-330-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Testosterone Injection Vials Due to Sterility Concerns

Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risks such as sterility failures in injectable drugs are categorized as Severe.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 20 vials of Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6 mg/66.6 mg/mL, 5 mL vials. The affected lots are 062915 (Exp 09/29/2015) and 071615 (Exp 10/16/2015). The product was distributed nationwide.

The recall was initiated because of observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished compounded sterile preparations.

Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 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 — Injectable Sterile Preparation
Hazard
Affected units
20

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 #: 062915
  • Exp 09/29/2015
  • and 071615
  • Exp 10/16/2015

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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Same manufacturer · Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

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Same hazard · sterility failure

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