The Recall Desk
SevereFDA (Drugs)·D-331-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Testosterone Injection Due to Sterility Concerns

Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a sterile injection, which poses a significant risk of serious injury or infection.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 5 mL vials. The recall affects Lot #060415 with an expiration date of 09/04/2015. 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 within their expiry dates.

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 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 — Compounded Sterile Preparation
Hazard
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 #: 060415
  • Exp 09/04/2015

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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