The Recall Desk
SevereFDA (Drugs)·D-312-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls LIPO B Injection Due to Sterility Concerns

Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in injectable drugs.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 76 vials of LIPO B Injection. The product is available in 2 mL, 12 mL, 15 mL, and 30 mL vials and is distributed nationwide. The recall covers specific lots with expiration dates ranging from September 12, 2015, to October 31, 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 compounded sterile preparations.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 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
76

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 (10)

  • Lot #: 061215
  • Exp 09/12/2015
  • 061915
  • Exp 09/19/2015
  • 070115
  • Exp 10/01/2015
  • 072315
  • Exp 10/23/2015
  • and 073115
  • Exp 10/31/2015

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

See all →

Same hazard · sterility

See all →