PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Reported: November 25, 2015 Initiated: September 3, 2015 #D-327-2016

Product Description

Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, 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

Units Affected
5 vials
Distribution
Nationwide
Location
Peoria, IL

Frequently Asked Questions

What product was recalled?
Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.. Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Units affected: 5 vials.
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-327-2016.