HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Recall Number: D-308-2016

Firm: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Classification: Class II

Status: Terminated

Report Date: 20151125

Initiation Date: 20150903

Termination Date: 20171229

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.

HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.