The Recall Desk
SevereFDA (Drugs)·D-305-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls Glycerin Opth Solution Due to Sterility Concerns

Kalman Health & Wellness is recalling Glycerin Opth Solution because poor sterile production practices may have compromised the sterility of the finished drug.

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 from non-sterile medical products.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling Glycerin Opth Solution, 10 mL dropper bottles, which are prescription-only products. The recall covers Lot #071515 with an expiration date of 10/15/2015. The product was distributed nationwide.

The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of assurance of sterility for the finished compounded sterile preparations.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Affected units
1

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 (2)

  • Lot #: 071515
  • Exp 10/15/2015

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 →