The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-311-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns

Kalman Health & Wellness is recalling HCG 10,000 Units/mL injections because poor sterile production practices created a lack of sterility assurance.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a lack of sterility assurance which poses a significant risk of serious adverse health consequences, are rated as Severe (4).

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling HCG 10,000 Units/mL Injection, which is available in various vial and prefilled syringe sizes. The product is prescription-only and 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 drugs. The recall covers all compounded sterile preparations within their expiry dates.

Affected lots include 080615, 081215, 081315, 081415, 1730-081715, 1730-081815, and 1730-081915. Consumers should stop using the product and consult their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, 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

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 (14)

  • Lot #: 080615
  • Exp 09/06/2015
  • 081215
  • Exp 09/12/2015
  • 081315
  • Exp 09/13/2015
  • 081415
  • Exp 09/14/2015
  • 1730-081715
  • Exp 09/17/2015
  • 1730-081815
  • Exp 09/18/2015
  • and 1730-081915
  • Exp 09/19/2015

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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