Skip to content
Recall Observatory FDA recall evidence

Drug product

HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

D-310-2016

September 03, 2015

Class II

Product summary

Firm
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Event
Event 72241
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-310-2016

Official wording

Reason: 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.

Code information: Lot #: 081315, Exp 09/13/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility