The Recall Desk
SevereFDA (Drugs)·D-325-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Sermorelin Injections Due to Sterility Concerns

Kalman Health & Wellness is recalling Sermorelin injections 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 agency classification is FDA Class II. The hazard involves a lack of sterility assurance in a subcutaneous injection, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL SUB-Q Injection. The affected product is packaged in 3 mL, 6 mL, 7.5 mL, 9 mL, or 10 mL vials and is available by prescription only. The recall covers 64 vials 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 source text does not specify the exact nature of the observations or the specific contaminants involved.

Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for instructions. The recall includes specific lot numbers and expiration dates ranging from September 2015 to September 2015.

The recalled product

Product
Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 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
64

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 (20)

  • Lot #: 080415
  • Exp 09/04/2015
  • 080515
  • Exp 09/05/2015
  • 080615
  • Exp 09/06/2015
  • 080715
  • Exp 09/07/2015
  • 081015
  • Exp 09/10/2015
  • 081115
  • Exp 09/11/2015
  • 081215
  • Exp 09/12/2015
  • 081315
  • Exp 09/13/2015
  • 081415
  • 081515
  • Exp 09/15/2015
  • 453-081715

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 · lack of sterility

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