The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-304-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns

Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in 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 source text identifies the recall as FDA Class II and cites a lack of sterility assurance, which poses a significant risk of serious health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling all compounded sterile preparations of Dual Test Cyp/ena 1:1 200 mg/mL Injection. The recall includes 5 mL and 100 mL vials distributed nationwide. The specific lots affected are 060815, 061615, 062915, 070615, 071615, 073015, and 080615, with expiration dates ranging from September 2015 to November 2015.

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 agency has classified this as a Class II recall.

Consumers and healthcare providers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 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

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 #: 060815
  • Exp 09/08/2015
  • 061615
  • Exp 09/16/2015
  • 062915
  • Exp 09/29/2015
  • 070615
  • Exp 10/06/2015
  • 071615
  • Exp 10/16/2015
  • 073015
  • Exp 10/30/2015
  • and 080615
  • Exp 11/08/2015

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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