The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-302-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Cyclosporin Eye Drops Due to Sterility Concerns

Essential Wellness Pharma is recalling specific lots of Cyclosporin 0.1% Opth Solution 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/property-damage reports or hospitalization reports are rated as Severe (4). While the source does not explicitly state hospitalizations, the lack of sterility assurance in a drug product is a significant safety hazard that aligns with the Severe classification for Class II recalls.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 7 dropper bottles of Cyclosporin 0.1% Opth Solution, 10 mL, Rx only. The product was distributed nationwide from the pharmacy located at 4625 N. University, Peoria, IL 61614.

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. The affected lots are 062915 (Exp 09/29/2015), 070915 (Exp 10/09/2015), 073015 (Exp 10/30/2015), 080315 (Exp 11/03/2015), and 080615 (Exp 11/06/2015).

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

The recalled product

Product
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, 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 (10)

  • Lot #: 062915
  • Exp 09/29/2015
  • 070915
  • Exp 10/09/2015
  • 073015
  • Exp 10/30/2015
  • 080315
  • Exp 11/03/2015
  • and 080615
  • Exp 11/06/2015

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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