The Recall Desk
CriticalFDA (Drugs)·D-0918-2017·Announced 2017-06-21

Complete Pharmacy Recalls Non-Sterile Human Chorionic Gonadotropin Vials

Complete Pharmacy and Medical Solutions LLC is recalling 49 vials of Human Chorionic Gonadotropin due to confirmed bacterial contamination.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Complete Pharmacy and Medical Solutions LLC is recalling 49 vials of Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection. The product is prescription-only and was distributed nationwide and in Puerto Rico.

The recall was initiated because an outside laboratory confirmed the presence of bacteria in the product after day 14. The affected lot is # 22016 with an expiration date of 1/30/2017.

Consumers and healthcare providers should stop using the recalled product immediately. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Affected units
49

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 # 22016
  • Exp 1/30/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: