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.
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 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.
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