The Recall Desk
SevereFDA (Drugs)·D-306-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide 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 FDA classified this as a Class II recall involving a lack of sterility assurance in compounded sterile preparations, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL SUB-Q Injection. The product is available in vial sizes ranging from 1.5 mL to 9 mL and is distributed nationwide. The recall is initiated due to observations associated with poor sterile production practices, which resulted in a lack of sterility assurance for the finished drugs.

The affected lots include 080415, 080515, 080615, 080715, 081015, 081115, 081215, 081315, 081415, 1702-081715, 1702-081815, and 1702-081915, with expiration dates ranging from September 2015 to September 2015. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected HCG injections and contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 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
49

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
  • Exp 09/14/2015
  • 1702-081715
  • Exp 09/17/2015

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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