Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Reported: November 25, 2015 Initiated: September 3, 2015 #D-305-2016
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.
Details
- Recalling Firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Units Affected
- 1 dropper bottle
- Distribution
- Nationwide
- Location
- Peoria, IL
Frequently Asked Questions
What product was recalled? ▼
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.. Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Units affected: 1 dropper bottle.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-305-2016.
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