The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-324-2016·Announced 2015-11-25

Sermorelin Injection Recalled Due to Lack of Sterility Assurance

Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromised 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, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk conditions.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Sermorelin 9 mg/10 mL SUB-Q Injection. The product is packaged in 3 mL, 5 mL, 6 mL, or 9 mL vials and is available by prescription only. The recall covers 7 vials distributed nationwide.

The recall was initiated due to observations associated with poor sterile production practices, resulting in a lack of sterility assurance for the finished drugs. The affected lots are 080515 (Exp 09/05/2015), 080715 (Exp 09/07/2015), 081115 (Exp 09/11/2015), and 081415 (Exp 09/14/2015).

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

The recalled product

Product
Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 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
7

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 (8)

  • Lot #: 080515
  • Exp 09/05/2015
  • 080715
  • Exp 09/07/2015
  • 081115
  • Exp 09/11/2015
  • and 081415
  • Exp. Date 09/14/2015

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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