The Recall Desk
SevereFDA (Drugs)·D-329-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Testosterone Cypionate Injection Due to Sterility Concerns

Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections 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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance in injectable drugs.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials. The recall covers two specific lots: Lot #070115 (Exp 10/01/2015) and Lot #071015 (Exp 10/10/2015). 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. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected vials immediately. The source text does not specify a particular action for disposal or return, but users should consult their healthcare provider regarding alternative treatments or next steps.

The recalled product

Product
Testosterone Cypionate 200 mcg/mL in Corn Oil 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 — Injectable Sterile Preparation
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 #: 070115
  • Exp 10/01/2015
  • and 071015
  • Exp 10/10/2015

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 →

Related recalls

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

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Same hazard · sterility failure

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