Home / Recalls / Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma / D-305-2016

D-305-2016 Class II Terminated

Recalled by Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma — Peoria, IL

FDA drug recall D-305-2016 was initiated by Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma on Sep 3, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a… The recall status is terminated (terminated Dec 29, 2017). Affected quantity: 1 dropper bottle.

Recall Details

Product Type: Drugs
Report Date: Nov 25, 2015
Initiation Date: Sep 3, 2015
Termination Date: Dec 29, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1 dropper bottle

Product Description

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

Reason for Recall

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Distribution Pattern

Nationwide

Code Information

Lot #: 071515, Exp 10/15/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-305-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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